Formalin Revision date:

2019-03-25

Safety data sheet MSDS015-001

1. Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier

Molecular formula: Mixture

Trade name: Formalin
Description: FORMED ALDEHIDE 10% volume / volume (4% weight / volume)

1.2. Relevant identified uses of the substance or mixture and uses advised against
In-vitro diagnostic laboratory reagent

1.3. Details of the supplier of the safety data sheet:

Milestone s.r.l.
Via Fatebenefratelli, 1/5
I-24010 Sorisole (BG)
Tel.: 0039.035.4128264
e-mail: marketing@milestonemedsrl.com
1.4. Emergency telephone number:
MILESTONE S.R.L. – tel: +39.035.4128264
From 8:30 to 12:30 and from 13:30 to 17:30, Monday to Friday.

2. Hazards identification
2.1. Classification of the substance or mixture
Classification according to Regulation (EC) n. 1272/2008
The product is classified as dangerous according to the provisions of EC Regulation 1272/2008 (CLP) (and
subsequent amendments and additions). The product therefore requires a safety data sheet in compliance
with the provisions of EC Regulation 1907/2006 and subsequent amendments.
Any additional information regarding health and / or environmental risks is provided in sections 11 and 12
of this sheet.

Classification and indications of danger:

Carcinogenicity, category 1B H350 May cause cancer
Germ cell mutagenicity, category 2 H341 Suspected of causing genetic defects.
Acute toxicity, category 4 H302 May be fatal if swallowed and enters airways
Skin sensitization, category 1 H317 May cause an allergic skin reaction

2.2. Label elements

Pittogram

Warning Danger
Indications of danger H302 May be fatal if swallowed and enters airways.
H317 May cause an allergic skin reaction.
H341 Suspected of causing genetic defects.
H350 May cause cancer.
Safety advice P201 Obtain special instructions before use.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P302+P352 IF ON SKIN: Wash with plenty of soap and water.
P308+P313 IF exposed or concerned: Get medical advice/attention
P333+313 If skin irritation or rash occurs: Get medical advice/attention
Additional risk Contains 10% formalin, Methyl Alcohol
descriptions
2.3. Other hazards
Based on the available data, the product does not contain PBT or vPvB substances in a percentage
higher than 0.1%.

3. Composition/information on ingredients
3.1. Substance

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Not applicable.

3.2. Mixture
Composition:
Registration
Name CAS No. EC no. Index Concentration Classification
number
Water 7732-18-5 231-791-2 >85%
Carcinogenic. 1B, Mutagenic 2,
Acute toxicity 3,
Skin irritation 1B, STOT SE 3,
Skin sensitivity 1,
H350, H341, H301, H311, H331,
H314, H317, Notes B and D.
Formaldeide 50-00-0 200-001-8 605-001-00-5 01-2119488953-20 1% - 5%
Concentration limits:
Skin Irrit. 2; H315: 5% ≤ C <25%
Skin Sens. 1; H317: C ≥ 0.2%
Eye Irrit. 2; H319: 5% ≤ C <25%
STOT SE 3; H335: C ≥ 5%
Skin Corr. 1B; H314: C ≥ 25%
Flammable liquid 2, Acute toxicity
3, STOT SE 1, H225, H301,
H311, H331, H370
Methyl Alcohol 67-56-1 200-659-6 603-001-00-X 01-2119433307-44 0.5-1.5%
Concentration limits:
STOT SE 1; H370: C ≥ 10%
STOT SE 2; H371: 3% ≤ C <10%
Note: Upper limit of the excluded range.
The full text of the hazard indications (H) is shown in section 16 of the sheet.

4. First aid measures

4.1. Description of first aid measures
Inhalation: Call a doctor immediately. Bring the subject to fresh air, away from the accident site. If breathing
is difficult, perform artificial respiration. Take appropriate precautions for the rescuer.
Skin contact: Remove contaminated clothing. Take a shower immediately. Consult a doctor immediately.
Eye contact: Remove any contact lenses. Wash immediately with plenty of water for at least 30/60 minutes,
opening the eyelids well. Consult a doctor immediately.
Ingestion: Consult a physician immediately. Do not induce vomiting unless expressly authorized by your
doctor.
4.2. Most important symptoms and effects, both acute and delayed
METHYL ALCOHOL
Dose-dependent acute effects
Skin: irritation, delipidization.
Nervous System: if swallowed or inhaled at high doses depression, headache, intoxication, dizziness, coma.
Eyes: irritation, if ingested, even serious changes.
First airways: irritation.
Lungs: irritation.
Digestive system: if ingested abdominal colic, vomiting.
Urogenital system: renal damage.

Chronic effects
Skin: irritation, scaling.
Nervous System: headache, insomnia, vertigo.
Eyes: irritation, ocular sequelae (even serious campimetric alterations).

FORMALDEHYDE
Acute dose dependent effects
Skin: irritation, sensitization, burn, necrosis.
Eyes: irritation, keratitis, conjunctivitis.
Nose: irritation, rhinitis.
First airways: irritation.
Lungs: irritation, sensitization, pneumonia, asthma.
Digestive system: if ingested abdominal colic, diarrhea, vomiting.

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Chronic effects
Skin: allergic dermatitis, eczema.
First airways: irritation, rhinitis.
Lungs: chronic bronchitis.
4.3. Indication of any immediate medical attention and special treatment needed
Provide emergency shower with viso-cular tray.

5. Firefighting measures
5.1. Extinguishing media
Suitable extinguishing media: The extinguishing media are: carbon dioxide, foam, chemical powder. For
leaks and spills of the product that have not ignited, the water spray can be used to disperse the flammable
vapors and protect the people involved in stopping the leak.
Unsuitable extinguishing media: Do not use water jets. Water is not effective for extinguishing the fire,
however it can be used to cool closed containers exposed to flames, preventing bursts and explosions.
5.2. Special hazards arising from the substance or mixture
HAZARDS DUE TO EXPOSURE IN THE EVENT OF FIRE
The product is not classified as flammable, however, in the event of thermal decomposition due to high
temperatures, substances potentially harmful to human health can develop, mainly carbon oxides and
carbon dioxide.
METHYL ALCOHOL
If possible, remove the containers of the substance from the fire site or cool down, because if exposed to
thermal radiation or if directly involved it can give rise to toxic fumes. Vapors can cause dizziness, fainting
or suffocation. Fire fighting operations must take into account the risk of explosion; therefore, fire fighting
personnel must act in a protected position. Containers may explode if exposed to fire.
FORMALDEHYDE
If possible, remove the containers of the substance from the fire site or cool down, because if exposed to
thermal radiation or if directly involved it can give rise to toxic fumes. If possible, remove the containers of
the substance from the fire site or cool, as it can cause polymerization if heated.
5.3. Advice for firefighters
General informations
Cool the containers with water jets to avoid decomposition of the product and the development of
substances potentially hazardous for health. Always wear the complete fire protection equipment. Collect
extinguishing water that must not be discharged into drains. Dispose of contaminated water used for
extinction and the remains of the fire according to the regulations in force.
Equipment
Normal fire fighting clothing, such as an open circuit compressed air breathing apparatus (EN137), fireproof
suit (EN469), flame retardant gloves (EN659) and firefighter boots (HO A29 or A30).

6. Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures
For those who do not intervene directly
Alert the personnel in charge of handling such emergencies. Move away from the accident area if you do
not have the personal protective equipment listed in Section 8.

For those who intervene directly

Remove all personnel who are not adequately equipped to cope with the emergency.
Wear appropriate protective equipment (including personal protective equipment referred to in section 8 of
the safety data sheet) to prevent contamination of the skin, eyes and personal clothing. Stop the leak if there
is no danger.
Make the area affected by the accident accessible to workers only after appropriate reclamation. Ventilate
the premises affected by the accident.
6.2. Environmental precautions
Prevent the product from entering sewers, surface waters, water tables.
6.3. Methods and material for containment and cleaning up
Vacuum the leaked product into a suitable container. Evaluate the compatibility of the container to be used
with the product, checking section 10.
Absorb the remainder with inert absorbent material.

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Ensure adequate ventilation of the area affected by the loss. Check the incompatibility for the material of
the containers in section 7. The disposal of the contaminated material must be carried out in accordance
with the provisions of point 13.
6.4. Reference to other sections
Any information regarding personal protection and disposal is given in sections 8 and 13.

7. Handling and storage

7.1. Precautions for safe handling:
Avoid contact with eyes and skin. Do not inhale vapors or mists. Do not eat, drink or smoke during use.
Wash hands after use. Avoid dispersion of the product in the environment.
7.2. Conditions for safe storage, including any incompatibilities
Store only in the original container. Store in a ventilated place. Keep containers tightly closed. Keep the
product in clearly labeled containers. Avoid overheating. Avoid violent shocks. Keep the containers away
from any incompatible materials, checking section 10.
7.3. Specific end use(s)
Information not available.

8. Exposure controls/personal protection

8.1. Control parameters
Normative references
Great Bretain: EH40 / 2005 Workplace exposure limits
Italy: Legislative Decree 9 April 2008, n.81.
EU OEL: Directive 2009/161/EU; Directive 2006/15/EC; Directive 2004/37/EC; Directive 2000/39/EC.
TLV-ACGIH: ACGIH 2014
Substance FORMALDEHYDE
TWA / Valore limite – 8 ore SETL 15min / Valore limite nel breve
periodo
ppm mg/m3 ppm mg/m3
WEL (GBR) 2 2,5 2 2,5
TLV-ACGIH 0,3 0,37

Predicted environmental concentration not to impact on the environment-PNEC.

Water Water Sediment Sediment Reference value for Reference value for water, Reference value
(fresh (sea (freshwater) (sea water) microorganisms intermittent release for the terrestrial
water) water) STP compartment
0.47
0.47 mg/L 2.44 mg/L 2.44 mg/kg 0.19 mg/L 4.7 mg/L 0.21 mg/kg
mg/L
Health-DNEL/DMEL derivative of non-effect Level
Effects on consumers Effects on workers
Effects on
Acute Acute Chronic Chronic Acute Acute Chronic Chronic
consumers
local systemic local systemic local systemic local systemic
Oral VND 4.1mg/kg
Inhalation 0.1mg/m3 3.2mg/m3 1mg/m3 VND 0.5mg/m3 9mg/m3
0.012mg/k
Dermal 102 mg/kg 0.037mg/kg 240mg/kg
g

Substance METHYL ALCOHOL

TWA/limit value – 8 hours SETL 15 min/limit value in the short term
ppm mg/m 3 ppm mg/m3
WEL 200
TLV 200 260
OEL 200 260
TLV-ACGIH 200 262 250 328
Predicted environmental concentration not to impact on the environment-PNEC..
Water (fresh Water (sea water) Sediment Sediment Reference value for the
water) (freshwater) (sea water) terrestrial compartment
154 mg/L 15.4 mg/L 570.4mg/kg 23.5 mg/kg
Health-DNEL/DMEL derivative of non-effect Level
Effects on consumers Effects on workers

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Effects on Acute Acute Chronic Chronic Acute Acute Chronic Chronic

consumers local systemic local systemic local systemic local systemic
Oral VND 8 mg/kg VND
Inhalation 50mg/m3 50 mg/m3 50 mg/m3 50 mg/m3 260 mg/m3 260 mg/m3 260 mg/m3 260 mg/m3
Dermal VND 8 mg/kg VND 8 mg/kg VND 40 mg/kg VND 40 mg/kg
Legend:
(C) = CEILING; INALAB = Inhalable Fraction; RESPIR = Breathable Fraction; TORAC = Thoracic Fraction.
VND = identified hazard but no DNEL / PNEC available; NEA = no expected exposure; NPI = no identified danger

Irrit = irritation
Rspr = respiratory
Oclr = eyepiece
Cfl = headache
IBE = biological indicator of exposure
Sen = awareness
A2 = a suspected human carcinogen
IBE METHYL ALCOHOL: Methanol in the urine, end of shift, 15mg / L..

Sampling methods
METHYL ALCOHOL: http://amcaw.ifa.dguv.de/substance/methoden/065-L-Methanol.pdf
FORMALDEIDE: http://amcaw.ifa.dguv.de/substance/methoden/057-L-Formaldehyde.pdf
8.2. Exposure controls
Considering that the use of adequate technical measures should always take priority over personal
protection equipment, ensure good ventilation in the workplace through effective local aspiration. Individual
protection devices must carry the CE mark which certifies their compliance with current regulations.
The product must be used in a closed cycle, in highly aerated environments and in the presence of strong
localized aspirations.
HAND PROTECTION
Protect your hands with class III A / J resistant gloves, permeation resistant, for example polychloropropene
gloves (ref. Standard EN 374).
For the final choice of material for work gloves, the following must be considered: compatibility, degradation,
breakage time and permeation.
In the case of preparations, the resistance of work gloves to chemical agents must be checked before use
as it is unpredictable. Gloves have a wear time that depends on the duration and mode of use.
SKIN PROTECTION
Wear category III work clothes with long sleeves and safety footwear for professional use (ref. Directive
89/686 / EEC and standard EN ISO 20344). Wash with soap and water after removing protective clothing.
EYE PROTECTION
We recommend wearing protective airtight goggles (ref. Standard EN 166).
RESPIRATORY PROTECTION
If the threshold value (eg TLV-TWA) of the substance or one or more of the substances present in the
product is exceeded, it is advisable to wear a mask with type A filter whose class (1, 2 or 3) must be chosen
in relation to the concentration limit of use. (ref. standard EN 14387). If there are gases or vapors of a
different nature and / or gases or vapors with particles (aerosols, fumes, mists, etc.) combined type filters
must be provided. The use of respiratory protection means is necessary if the technical measures adopted
are not sufficient to limit the exposure of the worker to the threshold values taken into consideration. The
protection offered by the masks is however limited.
In the event that the considered substance is odorless or its olfactory threshold is higher than the relative
TLV-TWA and in case of emergency, wear an open circuit compressed air breathing apparatus (ref.
Standard EN 137) or a breathing apparatus outdoor air (ref. standard EN 138). For the correct choice of the
respiratory protection device, refer to the EN 529 standard.
ENVIRONMENTAL EXPOSURE CHECKS.
Emissions from production processes, including those from ventilation equipment, should be checked for
compliance with environmental protection regulations.

9. Physical and chemical properties

9.1. Information on basic physical and chemical properties
a) Aspect Physical state: liquid
Color: Colorless
b) Odour pungent
c) Odour threshold No data available

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d) pH 7
e) Melting point / freezing point No data available
f) Initial boiling point and boiling + 100 ° C (approx.)
range:
g) Flash point No data available
h) Evaporation rate No data available
i) Flammability (solid, gas) Not applicable
j) Flammability or explosive limits
Upper No data available
Lower No data available
k) Vapour pressure No data available
l) Vapour density No data available
m) Relative density 1.010 g/cm3 (1.010 kg/L)
n) Solubility(ies) Partially soluble in water
o) Partition coefficient: noctanol/ The top layer is miscible with solvents.
water
p) Auto-ignition temperature No data available
q) Decomposition temperature No data available
r) Viscosity; No data available
s) Explosive properties Not applicable (absence of chemical groups associated with explosive
properties pursuant to the provisions of Annex I, Part 2, chapter 2.1.4.3
of the regulation (EC) 1272/2008 - CLP).
t) Oxidising properties Not applicable (lack of the requirements connected to the presence of
atoms and / or chemical bonds associated with oxidizing properties in
the molecules of the components pursuant to the provisions of Annex
I, Part 2, 2.13.4 of the regulation (EC) 1272/2008 - CLP).
9.2. Other information
Explosion hazard No
Solubility in solvents: Insoluble.

10. Stability and reactivity

10.1. Reactivity
METHYL ALCOHOL
Vapors form explosive mixtures with air.

FORMALDEHYDE
Aqueous solutions are stabilized with methanol, but tend to polymerize over time. The storage temperature
varies according to the concentration. The solutions> 25% are also corrosive. Decomposes due to heat.
10.2. Chemical stability
METHYL ALCOHOL
In combustion it develops formaldehyde
10.3. Possibility of hazardous reactions
METHYL ALCOHOL
Polymerizes exclusively if heated.
FORMALDEHYDE
Risk of explosion on contact with: nitromethane, nitrogen dioxide (at 180°C), hydrogen peroxide, phenol,
performic acid, nitric acid. May polymerize on contact with: strong oxidizing agents, alkalis. May react
dangerously with: hydrochloric acid, magnesium carbonate, sodium hydroxide, perchloric acid and aniline.
Forms explosive mixtures with air.
10.4. Conditions to avoid
Avoid overheating.
METHYL ALCOHOL
Avoid heating and naked flames.
FORMALDEHYDE
Avoid exposure to light, sources of heat and naked flames.
10.5. Incompatible materials
METHYL ALCOHOL
Oxidising substances.
FORMALDEHYDE

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Acids, alkalis, ammonia, tannin, strong oxidants, phenols and copper, silver and iron salts
10.6. Hazardous decomposition products
Due to thermal decomposition or in case of fire, potentially harmful gases and vapors can be released.
METHYL ALCOHOL
Heated by decomposition, it develops acrid and irritating fumes and vapors.
FORMALDEHYDE
Carbon oxides.

11. Toxicological information

11.1. Information on toxicological effectsEN
In the absence of experimental toxicological data on the product itself, the possible dangers of the health
product have been assessed on the basis of the properties of the substances contained, according to the
criteria set by the reference legislation for classification. Therefore, consider the concentration of the
individual dangerous substances possibly mentioned in section. 3, to assess the toxicological effects
deriving from exposure to the product.

Acute toxicity
Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is classified for this hazard class in category 4
H302.
METHYL ALCOHOL
LD50 (Oral).> 1187 mg / kg rat
LD50 (Cutaneous) .17100 mg / kg rabbit
LC50 (Inhalation) .128.2 g / m3 / 4h rat
FORMALDEHYDE
LD50 (Oral) .100 mg / kg Rat
LD50 (Cutaneous) .270 mg / kg Rabbit
LC50 (Inhalation) .0.588 mg / l / 4h Rat

Skin corrosion / irritation

Based on the evaluation of the classification of the components and the classification provisions of Annex I,
Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is not classified for this hazard class.
The product is corrosive and causes severe burns and blistering on the skin, which may appear even after
exposure. Burns cause severe burning and pain.
The skin lesions may include erythema, edema, papules, vesicles, pustules, scales, fissures and exudative
phenomena, which vary according to the phases of the disease and the affected areas. In the acute phase
erythema, edema and exudation prevail. In chronic phases, scales, dryness, fissuring and thickening of the
skin prevail.
METHYL ALCOHOL
Repeated or prolonged contact with the substance in liquid form can cause skin irritation: dermatosis,
erythema and desquamation.
FORMALDEHYDE
It can cause irritative to caustic type injuries depending on the concentration. Formaldehyde is irritating to
human skin.
Experimental studies confirm the irritant action observed in humans. Aqueous solutions of formaldehyde
(0.1% to 20%) are irritants for rabbit skin. (OECD, 2002)

Serious eye damage / eye irritation

Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is not classified for this hazard class.
In contact with the eyes it causes serious injuries and can cause corneal opacity, iris lesion, irreversible eye
coloration.
METHYL ALCOHOL
The substance inhaled is irritating. In liquid form it can cause conjunctivitis, superficial lesions of the cornea
and chemosis.

Respiratory or skin sensitization

Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is classified as Skin Sens. 1 H317.

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The contact of the product with the skin causes sensitization (contact dermatitis). Dermatitis originates
following an inflammation of the skin, which starts in the skin areas that come into repeated contact with the
sensitizing agent.
FORMALDEHYDE
Skin sensitization
The substance has sensitizing power. In numerous studies on different models (Buehler's mouse test and
guinea pig maximization test) indicate that formaldehyde is a skin sensitizer in animals where it induces a
moderate to strong response to non-irritating concentrations (INRS, 2011)

Respiratory sensitization
Exposure, even brief, to an atmospheric concentration of 50 ppm of formaldehyde may be responsible for
severe bronchospasm and severe caustic lesions of the respiratory tract (acute pulmonary edema, tracheal
and bronchial ulcerations). Exposure of healthy, non-smoking volunteers at 2 ppm for 40 minutes, at rest or
during moderate exercise (10 minutes out of 40), did not alter the respiratory rates over the next 24 hours
and did not induce bronchial hyperreactivity (INRS, 2011).
Specially designed studies (IgE tests, cytokine secretion profiles of lymph node cells) revealed no evidence
of respiratory sensitization in mice. (OECD, 2002).

Germ cell mutagenicity

Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is classified as Muta.2 H341.
The product is to be considered with suspicion for possible mutagenic effects. However, sufficient
information is not available to definitively demonstrate hereditary genetic alterations.
METHYL ALCOHOL
No human data are available. Methanol provided negative results in the Ames test, with or without metabolic
activation. In culture it induced point mutations on mouse lymphoma cells. In vivo increases the frequency
of chromosomal aberrations in mice and grasshoppers. In the mouse, the response is dose-dependent and
is accompanied by increased frequency of exchanges between sister chromatids and micronuclei in bone
marrow cells.
FORMALDEHYDE
Formaldehyde is a direct genotoxic agent that has provided positive results on most assays on bacteria,
yeasts, fungi, insects, nematodes and
mammalian cells. In vivo it is genotoxic in both humans and experimental animals.

Carcinogenicity
Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and subsequent amendments, the mixture is classified as Carc. 1B
H350.
The product should be considered carcinogenic to humans. There are sufficient elements to believe that
human exposure to the substance contained in the product may cause the development of tumors.
FORMALDEHYDE
Numerous epidemiological studies and meta-analyzes have shown causal relationship between
formaldehyde exposure and cancer in humans. There is a strong increase in the incidence of
nasopharyngeal cancer, cancer of the nasal sinuses and cancer of the lymphohaematopoietic system, in
particular myeloid leukemia (the substance, due to inhalation exposure, causes genetic damage in the nasal
tissues in both humans and experimental animals). - The International Agency for Research on Cancer
(IARC) allocates formaldehyde in group 1 (ascertained carcinogenic to humans), based on evidence of
sufficient carcinogenicity in humans (nasopharyngeal cancer and leukemia and there is also a positive tumor
association of sinuses) and in animals (IARC, 2012).
The US National Toxicology Program (NTP) lists formaldehyde in the Thirteenth Report on Carcinogens
allocating it to the category of carcinogens recognized for humans (US DHHS, 2014). The US Environmental
Protection Agency (EPA) is reviewing the formaldehyde assessment (USEPA file online 2014).

Reproductive toxicity
Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is not classified for this hazard class.
METHYL ALCOHOL
- Adverse effects on sexual function and fertility: Data not available.
- Adverse effects on development: In pregnant women exposed to 20000 ppm of substance, 7h / day for the
whole duration of gestation or even only from the 7th to the 15th day of gestation, the substance caused a

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slight maternal toxicity and a strong incidence of congenital malformations (over-numerary or rudimentary
ribs, malformations of the urinary or cardiovascular system).
- Effects on breastfeeding or breastfeeding: Data not available.
FORMALDEHYDE
- Adverse effects on sexual function and fertility: No data on reproductive toxicity are available.
- Adverse developmental effects: Available epidemiological studies indicate an increase in spontaneous
abortions and a decrease in birth weight.
These results are equivocal since the role of other risk factors cannot be excluded.
- Effects on breastfeeding or breastfeeding: No data are available on effects on breastfeeding or through
breastfeeding.

Specific target organ toxicity (STOT) - single exposure

Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is not classified for this hazard class
METHYL ALCOHOL
The substance has action on the CNS where it initially causes intoxication, then more or less profound
disturbances of consciousness sometimes accompanied by
convulsions, respiratory depression and cardiovascular collapse.
FORMALDEHYDE
It has an irritant to caustic action for the respiratory system. Following acute inhalation exposure, irritation
of the eyes, nose, throat and lungs is observed, as well as cellular alterations, such as ciliary lesions and
cellular swelling of the upper respiratory tract. In humans, severe ulcerations of the gastrointestinal tract
have been observed after ingestion. (OECD, 2002).

Specific target organ toxicity (STOT) - repeated exposure

Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is not classified for this hazard class.
METHYL ALCOHOL
Epidemiological studies on workers exposed to long-term substance vapors have shown the presence of
visual disturbances affecting the optic nerve and the retina, persistent and relapsing headaches. Repeated
or prolonged contact with the substance in liquid form can cause skin irritation: dermatosis, erythema and
desquamation.
FORMALDEHYDE
In long-term exposures there may be irritation of the ocular and respiratory mucous membranes, symptoms
of chronic bronchitis, alteration of the functional respiratory tests, lesions of the respiratory epithelium.
Epidemiological studies also indicate manifestations of psycho-organic syndrome. Chronic skin irritation has
also been observed.

Danger in case of aspiration

Based on the evaluation of the classification of the components and the classification provisions of Annex
I, Part 3 of the reg. (CE) 1272/2008 and s.m.i., the mixture is not classified for this hazard class.

Metabolism, kinetics, mechanism of action and other information

METHYL ALCOHOL
The substance can be absorbed by ingestion, inhalation or through skin contact. It is rapidly distributed in
the body's total water. The half-life is about 24 hours. Metabolism occurs in the liver. The 1st stage involves
the oxidation of methanol to formaldehyde by the hepatic alcohol dehydrogenase, a non-specific enzyme
that also has affinity for ethanol and butanol. The relative affinity of the alcohol dehydrogenase for ethanol
and methanol is approximately 20: 1; that is, this stage is limiting because it is linked to a saturation process.
In the 2nd stage the formaldehyde is oxidized by the aldehyde dehydrogenase in formic acid or formate, in
relation to the pH. The 3rd stage, which leads to the formation of carbon dioxide, is controlled by the
metabolic pathway of the compounds at a carbon atom (system under the dependence of a derivative of
folic acid); is the limiting step of biotransformation. This explains the accumulation of formates in the body
in the event of massive or repeated administration of methanol. The elimination of methanol and its
metabolites occurs with the exhaled air (methanol and carbon dioxide) and with the urine (methanol and
formates). This process is slow, particularly when compared with ethanol. In primates the metabolic process
is about 50% slower than in rodents. The urinary concentration of methanol, well correlated with blood
concentration, is a good indicator of the spread of the substance. The existence of a latency phase prior to
the appearance of specific toxic effects suggests that these are not due to the substance itself but to its
metabolites. The mechanism of ocular toxicity has not yet been elucidated, although it is likely that it is due

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to the presence of formic acid and not of formaldehyde. The accumulation of formic acid coincides with the
metabolic acidosis and with the toxic effects on the central nervous system.

FORMALDEHYDE
Formaldehyde is a metabolic intermediate in all cells. It is produced during the metabolism of serine, glycine
and choline and also by demethylation of the N-, S- and O-methyl compounds. It is rapidly absorbed from
the respiratory and gastrointestinal tract and poorly absorbed following skin application. It is metabolized to
formate by the enzyme formaldehyde dehydrogenase and subsequently the carbon atom is oxidized to
carbon dioxide or incorporated into purines, thymidines and amino acids. Both formaldehyde and formate
do not accumulate in tissues. It is distributed in richly vascularized organs, in tissues with rapid cellular
turnover (hematopoietic organs, gastrointestinal mucosa) and in those with high protein synthesis (exocrine
pancreas, salivary glands). After absorption, formaldehyde forms bonds with proteins and nucleic acids at
the contact site. Most are excreted with the exhaled air in the form of carbon dioxide, another portion is
eliminated in the urine.

Information on likely routes of exposure

The main potential routes of exposure are inhalation, skin contact and ingestion. Worker exposure is by skin
contact and inhalation.

Symptoms related to physical, chemical and toxicological characteristics

Acute effects: the product is toxic, causing poisoning by inhalation, cutaneous absorption and ingestion.
Inhalation of the product, the poisoning can occur, depending on the case, with different symptoms, which
may include: burning and irritation of the eyes, mouth, nose and throat, cough, difficulty breathing, dizziness,
headache, nausea and vomiting. In the most serious cases the inhalation of the product can cause:
inflammation and edema of the larynx and bronchi, chemical pneumonia and pulmonary edema, increase
or reduction in heart rate, abundant salivation or blood sputum, loss of consciousness, behavioral disorders
(depression or euphoria). By skin contact the poisoning can manifest itself with symptoms that may include:
increased skin temperature, swelling, itching, headache, respiratory disorders and sometimes burns or
causticizations. Even small amounts ingested can cause significant health problems, which may include the
following symptoms: burns or injuries to the mouth and throat, nausea, abdominal pain, vomiting, diarrhea,
excessive sweating, convulsions, unconsciousness.
Vapors and / or powders are caustic for the respiratory system and can cause pulmonary edema, whose
symptoms sometimes become manifest only after a few hours. Exposure symptoms may include: burning
sensation, coughing, asthmatic breathing, laryngitis, shortness of breath, headache, nausea and vomiting.
Ingestion can cause burns to the mouth, throat and esophagus; vomiting, diarrhea, edema, swelling of the
larynx and subsequent suffocation. Perforation of the gastrointestinal tract may also occur.
The product can produce irreversible, non-lethal damage after a single exposure by inhalation, skin
absorption and ingestion.

Immediate, delayed effects and chronic effects from short and long term exposure
METHYL ALCOHOL
In case of serious poisoning, both by digestive and inhalation routes, the latency time for the onset of
symptoms is variable, from 10 to 48 hours, depending also on the ingested dose. There are: - non-specific
symptoms such as CNS depression with intoxication syndrome, then more or less profound disorders of the
conscience sometimes accompanied by convulsions, respiratory depression and cardio-vascular collapse.
Own symptoms of methanol intoxication: marked metabolic acidosis with large and rapid breath of the
Kussmaul type. You can arrive at an arterial pH below 7, a significant reduction in bicarbonates and an
increase in lactates; - visual disturbances that can occur late, from the 2nd to the 4th day and which are
manifestations of retrobulbar optic neuritis. There is bilateral mydriasis with abolition of the photomotor
reflex, reduction of visual acuity that can develop into complete blindness and a concentric narrowing of the
visual field. There is great variability among individuals for methanol resistance. In the most serious cases,
death may occur due to respiratory failure, or, even after severe poisoning, total recovery may occur, but
the ocular sequelae are relatively frequent (reductions in the visual field, complete blindness).
Epidemiological studies on workers exposed to long-term substance vapors have shown the presence of
visual disturbances affecting the optic nerve and the retina, persistent and relapsing headaches. Repeated
or prolonged contact with the substance in liquid form can cause skin irritation: dermatosis, erythema and
desquamation. The substance inhaled has irritating power for the eyes and the respiratory system.

FORMALDEHYDE

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Olfactory perception and sensitivity to irritant effects vary from one individual to another. Following inhalation
exposure to high concentrations of substance may cause bronchospasm with severe caustic respiratory
tree lesions, acute pulmonary edema, tracheal and bronchial ulcers. Following
ingestion high amounts, at high concentrations, cause caustic lesions. These risk being underestimated
because the mucosa is preserved intact. Systemic intoxication is responsible for poly-visceral damage
manifested by convulsive coma, hepatic cytolysis and cardiovascular disorders, moderate haemolysis and
tubular nephropathy. In severe cases there is intense metabolic acidosis and consumption coagulopathy.
In the short term the complications are perforations and bleeding associated with respiratory disorders due
to laryngeal edema, inhaled pneumopathy or exo-tracheal fistulas. Further evolution can be a digestive
stenosis. The substance has high allergenic power and can cause anaphylactic shock. In long-term
exposures there may be irritation of the ocular and respiratory mucous membranes, symptoms of chronic
bronchitis, alteration of the functional respiratory tests, lesions of the respiratory epithelium. Epidemiological
studies also indicate manifestations of organic psycho-syndrome.

12. Ecological information

12.1. Toxicity
METHYL ALCOHOL
LC50 - Fish 15.4 g / l Lepomis macrochirus
EC50 - Crustaceans> 10 g / l Daphnia magna
NOEC Chronic Fish 7.9 g / l Oryzias latipes

FORMALDEHYDE (4%)
EC50 - Crustaceans 5.8 mg / l / 48h
EC50 - Algae / Aquatic Plants> 3.48 mg / l / 72h
NOEC Chronic Fish> 48 mg / l
12.2. Persistence and degradability
METHYL ALCOHOL
It is expected to biodegrade.

FORMALDEHYDE
Gaseous formaldehyde released into the atmosphere degrades by reaction with photochemically
produced hydroxyl radicals (reaction half-life of about 41 hours).
It undergoes direct photolysis as it absorbs into the environmental UV spectrum (reaction half-life of about
6 hours) (HSDB, 2014).
Polymerizes rapidly in water.
Biodegrades both in aerobic and anaerobic conditions in water and on the ground.
Formic acid is formed by slow oxidation; complete oxidation leads to carbon dioxide and water.
12.3. Bioaccumulative potential
ALCOOL METILICO
Sulla base del log Kow è stato stimato un BCF di 0,2. Sulla base dei valori di BCF stimati e riportati non si
prevede che la sostanza bioconcentri significativamente in organismi acquatici.
FORMALDEIDE
La bioconcentrazione non è significativa. Dati sperimentali con una varietà di pesci e animali invertebrati
mostrano che non bioconcentra (HSDB,2014).
12.4. Mobility in soil
METHYL ALCOHOL
Based on the Kow log, a BCF of 0.2 was estimated. Based on the estimated and reported BCF values, the
substance is not expected to bioconcentrate significantly in aquatic organisms.
FORMALDEHYDE
Bioconcentration is not significant. Experimental data with a variety of invertebrate fish and animals show
that it is not bioconcentra (HSDB, 2014).
12.5. Results of PBT and vPvB assessment
Based on the available data, the product does not contain PBT or vPvB substances in a percentage higher
than 0.1%..
12.6. Other adverse effects
Methyl alcohol
Some plants exposed to air containing methanol (conc. Between 0.4 and 2.5 mg / m3) for 14 days, have experienced
growth delays.
Formaldehyde

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Bean and barley plants can absorb leafy formaldehyde.

13. Disposal considerations

13.1. Waste treatment methods
Product:
Reuse, if possible. Product residues are to be considered special hazardous waste. The dangerousness of
the waste that partly contains this product must be assessed according to the laws in force. Disposal must
be entrusted to an authorized waste management company, in compliance with national and local
regulations.
Contaminated containers
Contaminated packaging must be sent for recovery or disposal in compliance with national waste
management regulations.

14. Transport information

14.1. UN number
ADR/RID: Non applicabile IMDG: Non applicabile IATA: Non applicabile
14.2. UN proper shipping name
ADR/RID: n.a.
IMDG: n.a.
IATA: n.a.
14.3. Transport hazard class(es)
ADR/RID: IMDG: IATA:
14.4. Packing group
ADR/RID: IMDG: IATA:
14.5. Environmental hazards
ADR/RID: IMDG Marine pollution: IATA:
14.6. Special precautions for user
No data available
14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code
Irrelevant information

15. Regulatory information

Classification according to EC directives:
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
Seveso category: None.
Restrictions relating to the product or the substances contained according to Annex XVII Regulation (EC)
1907/2006.
Product: Point 3
Substances in Candidate List (Art. 59 REACH): None.
Substances subject to authorization (Annex XIV REACH): None.
Substances subject to the Rotterdam Convention: None.
Substances subject to the Stockholm Convention: None.
Sanitary checks.
Workers exposed to this hazardous chemical agent must be subjected to health surveillance carried out
according to the provisions of article 41 of Legislative Decree 81 of 9 April 2008 in the event that the
assessment referred to in art. 236 of the same decree highlighted a health risk.

Product not intended for the uses foreseen by Dir. 2004/42/CE.

15.2. Chemical safety assessment
A chemical safety assessment was carried out for the following contained substances: FORMALDEHYDE.

16. Other information

Text of the hazard indications (H) mentioned in sections 2-3 of the sheet:
Flam. Liq. 2 Flammable liquid, category 2
Carc. 1B Carcinogenicity, category 1B
Muta. 2 Germ cell mutagenicity, category 2
Acute Tox. 3 Acute toxicity, category 3

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STOT SE 1 Specific target organ toxicity - single exposure, category 1

Skin Corr. 1B Skin corrosion, category 1B
Skin Sens. 1 Skin sensitization, category 1
H225 Highly flammable liquid and vapour
H350 May cause cancer
H341 Suspected of causing genetic defects.
H301 Toxic if swallowed
H311 Toxic in contact with skin.
H331 Toxic if inhaled.
H370 Causes damage to organs.
H314 Causes severe skin burns and eye damage
H317 May cause an allergic skin reaction
Note B Certain substances (acids, bases, etc.) are placed on the market in aqueous solution at
different concentrations and therefore require different classification and labeling as the
hazards vary depending on the concentration. In Part 3, for substances accompanied by
Note B, a general name such as "nitric acid ...%" is used. In this case the supplier must
indicate the percentage concentration of the solution on the label. The concentration
expressed in percentage is always intended weight / weight, unless otherwise indicated
Note D Some substances that tend spontaneously to polymerization or decomposition are generally
placed on the market in a stabilized form and are in this form which are listed in Part 3.
However, these substances are sometimes placed on the market in a non-stabilized form.
In this case the supplier must specify on the label the name of the substance followed by
the word "non-stabilized"
LEGEND:
- ADR: European agreement for the transport of dangerous goods by road
- CAS NUMBER: Number of the Chemical Abstract Service
- EC50: Concentration that gives effect to 50% of the population subject to testing
- CE NUMBER: Identification number in ESIS (European archive of existing substances)
- CLP: EC Regulation 1272/2008
- DNEL: Derived level without effect
- EmS: Emergency Schedule
- GHS: Global harmonized system for the classification and labeling of chemical products
- IATA DGR: Regulation for the transport of dangerous goods of the International Air Transport Association
- IC50: Immobilization concentration of 50% of the population subjected to tests
- IMDG: International maritime code for the transport of dangerous goods
- IMO: International Maritime Organization
- INDEX NUMBER: Identification number in the Annex VI of the CLP
- LC50: Lethal concentration 50%
- LD50: 50% lethal dose
- OEL: Occupational exposure level
- PBT: Persistent, bioaccumulating and toxic according to REACH
- PEC: Predictable environmental concentration
- PEL: Predictable level of exposure
- PNEC: Predictable no-effect concentration
- REACH: EC Regulation 1907/2006
- RID: Regulation for the international transport of dangerous goods by train
- TLV: Threshold Limit Value
- TLV CEILING: Concentration that must not be exceeded during any time of occupational exposure.
- TWA STEL: Short-term exposure limit
- TWA: Average weighted exposure limit
- VOC: Volatile organic compound
- vPvB: Very persistent and very bioaccumulative according to REACH
- WGK: Class of aquatic hazard (Germany).

Note to the user.

The information contained in this sheet is based on the knowledge available from us at the date of the latest
version. The user must make sure of the suitability and completeness of the information in relation to the
specific use of the product.
This document must not be interpreted as a guarantee of any specific property of the product.

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Since the use of the product does not fall under our direct control, it is the user's obligation to observe the
laws and regulations in force concerning hygiene and safety under his own responsibility. No liability is
assumed for improper use.
Provide adequate training for the staff involved in the use of chemical products.

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