CPSR Soap

Name of the product: Soap flakes Nr TRAPL / Version no.
:
TRAPL -093-17/ Ver 1
Manufacturer: Jaguar Tomasz Chwilowicz Issue date: 17/09/2020
COSMETIC PRODUCT
SAFETY ASSESSMENT
PRODUCT CATEGORY: Cosmetic
REQUIRMENTS: Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30
November 2009 on cosmetic products
CLIENT NAME: Jaguar Tomasz Chwilowicz, ul. Dworcowa 62, 62-400 Słupca
Notes:
Any change to the chemical composition, scope and usage, or trade name of the product should
be re-examined by the safety assessor.
This safety assessment does not apply to people who are allergic to any component of the
formulation.
The safety assessor can only estimate based on the current knowledge, recommendation from
the authorities and European regulations that the cosmetic product poses no risk to human
health when used under normal or reasonably foreseeable conditions of use.
Intertek Poland Sp. z o.o. Intertek Poland Sp. z o.o.

Ul. Cyprysowa 23 B; 02-265 Warszawa Laboratorium Badawcze
Tel.: +48 (0) 22 886-32-80, Fax +48 (0) 22 863 33 15 Helenów 6 A, 09-504 Lucień
www.intertek.pl, E-mail: labtest.poland@intertek.com Tel.: +48 (0)24 235 71 81, Fax +48 (0)24 235 93 41
Regon: 140158534, NIP: 5222778398, KRS 0000236602 E-mail: laboratorium.polska@intertek.com
Name of the product: Soap flakes Nr TRAPL / Version no.:
PART A
COSMETIC PRODUCT SAFETY INFORMATION
PRODUCT: Soap flakes
TYPE OF PRODUCT: Rinse-off
NOMINAL SIZE: 100 g
TYPE OF PACKING: kraft paper one side smoothed
1. QUANTITATIVE AND QUALITATIVE COMPOSITION OF THE COSMETIC PRODUCT

INCI OR CHEMICAL NAME CAS EINECS /ELINCS ACTIVITY OF MAXIMUM MAXIMUM
SINGLE VALUE CONCENTRATION
INGREDIENT [%] OF SINGLE
[%] INGREDIENT IN
PRODUCT
[%]
AQUA 7732-18-5 231-791-2
55,995 55,995
100
SODIUM DODECYL SULFATE 151-21-3/1335- 205-788-1/603- 100 18 18
72-4/8012-56-4 752-3/616-937-9
POLYVINYL ALCOHOL 557-75-5/9002- 209-183-3/618- 100 10 10
89-5 340-9
COCAMIDE MEA 68140-00-1 100 4,0 4,0

GLYCERIN 56-81-5 200-289-5 100 3,0 3,0
SODIUM LAURETH SULFATE 1335-72-4 100 1,6 1,6
COCONUT OIL 8001-31-8 100 1,0 1,0
BENZALKONIUM CHLORIDE 8001-54-5 100 0,6 0,6
PHENOXYETHANOL 122-99-6 204-589-7 91,5 0,3 0,2745
ETHYLHEXYLGLYCERIN 70445-33-9 - 11,5 0,0345
COLORANTS - - 100 0,005 0,005
PARFUM - - 100 0,5 0,5
2. PHYSICAL/CHEMICAL CHARACTERISTICS AND STABILITY OF THE COSMETIC PRODUCT

APPEARANCE: Soap in the form of flakes in the SOLUBILITY IN WATER: N/A
shape of a rectangle with rounded corners
COLOUR: Suitable for the components used, white DENSITY: N/A
and light pink
ODOUR: Characteristic for the raw materials used, PARTICLES SIZE: N/A
without any foreign smells
pH VALUE: 7,6 Log Kow: N/A
MELTING TEMPERATURE: N/A VAPOUR PRESSURE: N/A
N/A-not available

STABILITY OF THE COSMETIC PRODUCT
PRODUCT STABILITY:
The study was conducted / monitored for 6 days at 25 ° C and 40 ° C. Take into consideration
(appearance, color, smell, application). The samples maintained their appearance, color and odor
under all conditions used during the test. The packaging, in which the sample was placed, retained its
appearance and functionality under all conditions used during the test. The result of the report
confirms the stability of the sample in all these conditions monitoring.
PRODUCT DURABILITY
The product has a shelf life of 1 year from the production date.
METHODOLOGY OF RESEARCH:
Stability studies are carried out in accordance with the procedures and internal methods. *
* a statement on the durability of the product
3. MICROBIOLOGICAL QUALITY
MICROBIOLOGICAL SPECIFICATION
The product has been tested for microbiological presence (report no GLHGR071209072CM)
PARAMETER METHODOLOGY RESULTS
Total microbial count EP 2.6.12 <1.0x101 CFU / g
EP 2.6.13
Presence of P.aeruginos No presence was found in 10 g
of the sample
Salmonella Absent in 10 g
Enterobacteria <1.0x101 MPN / g
The number of yeast <1.0x101 CFU / g
The number of molds <1.0x101 CFU / g
The presence of Absent in 10 g

Escherichia coli

The presence of Clostrid Absent in 10 g
Presence of Salmonella Absent in 10 g
4. IMPURITIES, TRACES, INFORMATION ABOUT THE PACKAGING MATERIAL
The product may contain traces of heavy metals, the presence of which is technically unavoidable. The
presence of heavy metals whose limits are controlled does not affect the safety of the product. The
product has been tested for the content of heavy metals GZ0712197571 / CHEM:
Type Result Maximum level
Arsen (As) Not detected 5 ppm

Lead (Pb) Not detected 20 ppm
Cadmium (Cd) Not detected 5 ppm
Antimony (Sb) Not detected 10 ppm
Mercury (Hg) Not detected 1 ppm
Nickel (Ni) Not detected 10 ppm
The product may contain impurities derived from raw materials in the form of traces of starting and
intermediate synthesis products. Information on possible contamination is provided in section 8 of this
report for each substance. The manufacturer should ensure that the raw materials meet the
requirements of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30
November 2009 regarding cosmetic products regarding their purity.
The packaging intended for sale is made of paper. The packaging materials are characterized by high
chemical resistance, are non-toxic, harmless to humans, commonly known and used in the packaging
industry. The packaging may contain traces of heavy metals and monomers.
Cosmetic product is manufactured according to the standards of Good Manufacturing Practice GMP.
5. NORMAL AND REASONABLY FORESEEABLE USE
The product is intended for adults for external use only. The product is developed to be applied on
hand and belongs to the rinse-off cosmetic products. Other use of the product or different method of
application are not expected.

6. EXPOSURE TO THE COSMETIC PRODUCT
The exposure to the cosmetic product has been determined in accordance with Regulation (EC) No
1223/2009 (2013/674/EU) and SCCS'S Notes of Guidance SCCS/1564/15 for the testing of cosmetics
substances and their safety evaluation.
PRODUCT TYPE: flake soap
TARGET POPULATION: (<16+) and (16+) women and men
ESTIMATED DAILY APPLICATION DOSE [g]: 21.0
DAILY EXPOSURE DOSE [g / day]: 42.0
FREQUENCY OF USE [per day]: 2
TOTAL DAILY EXPOSURE DOSE [mg / kg / day]: 3.5
* BASED ON AN AVERAGE BODY WEIGHT OF 61 KG
LEVEL OF SKIN EXPOSURE [mg / cm2]: 0.12
PLACE OF CONTACT WITH THE HUMAN BODY: hands, body
CONTACT AREA [cm2]: 17 500
APPLICATION METHOD: rinse off product
RETENTION FACTOR: 0.01
INTENDED ROUTES OF EXPOSURE: hands / body
SECONDARY ROUTES OF EXPOSURE: digestive system
7. EXPOSURE TO THE COSMETIC PRODUCT

CHEMICAL NAME OR INCI MAX CONTENT SYSTEMIC NO MARGIN OF DERMAL RESTRICTIONS AS PER
OF THE EXPOSURE OBSERVAB SAFETY MOS EXPOSURE REQUIRMENTS
SINGLE DOSAGE LE LEVEL OF EC No 1223/2009
INGREDIENT (SED) ADVERSE [mg/cm2]
IN THE [mg/kg EFFECT
FINISHED bw/day] LEVEL
PRODUCT (NOEAL)
[%] [mg/kg
bw/day]
AQUA 55,995 None
1,959825 - - 0,06719
SODIUM DODECYL SULFATE 18 0,63 - - 0,02160 None
POLYVINYL ALCOHOL 10 0,35 - - 0,01200 None

COCAMIDE MEA 4,0 0,14 - - 0,00480 None

GLYCERIN 3,0 0,105 250 2380,9 0,00360 None
SODIUM LAURETH SULFATE 1,6 0,056 - - 0,00192 None
COCONUT OIL 1,0 0,035 - - 0,00120 None
BENZALKONIUM CHLORIDE 0,6 0,021 - - 0,00072 None
PHENOXYETHANOL 0,2745 Maximum concentration in the
0,009608 80 8326,4 0,00033 finished product - 1%
ETHYLHEXYLGLYCERIN 0,0345 0,001208 - - 0,00004 None
COLORANTS 0,005 0,000175 - - 0,00001 None
PARFUM 0,5 The presence of the substance
must be indicated in the list of
ingredients referred to in Article
19(1)(g) when its concentration
exceeds:—
0,001 % in leave-on products —
0,0175 - - 0,00060 0,01 % in rinse-off products
All ingredients are well known and have a history of safe use, while sales in the market, with no
significant number of adverse events.
The report is based only on the ingredient list given to the assessment and assumes that this list is
accurate and that there is no additional components or additional information that are not listed. If
this information is incorrect, please contact the safety assessor with correct data.
8. TOXICOLOGICAL PROFILE OF THE SUBSTANCES
The safety evaluation of a finished cosmetic product was based on the available toxicological data for
all substances. The data sources including: in vivo tests, in vitro tests, human data from clinical
observation and compatibility tests in human volunteers, data from data banks (TOXNET, RTECS, HERA,
PUBCHEM, PUBMED), published literature, publicly available sources and databases: (CosIng
(European Commission database with information on cosmetic substances and ingredients), OECD
(Organisation for Economic Co-operation and Development), ESIS (European Chemical Substances
Information System), HSDB (Hazardous Substances Data Bank), ECHA (European Chemical Agency)
opinions from CIR (Cosmetic Ingredient Review), SCCS (Scientific Committee on Consumer Safety), US
EPA (US Environmental Protection Agency), ‘in house’ experience, data obtained from the raw
materials suppliers, including QSAR structural tests, relevant data on analogous compounds.
INCI NAME: AQUA

OTHER NAMES: Water; Dihydrogen oxide; Distilled
water; Water vapor; 7732-18-5; Steam
CAS: 7732-18-5
EINEC: 231-791-2
FUNCTION: •SOLVENT
PHYSICAL AND CHEMICAL PROPERTIES
MOLECULAR FORMULA: H2O (https://pubchem.ncbi.nlm.nih.gov/compound/water#section=Top)

MOLECULAR WEIGHT: 18.01528 g/mol (https://pubchem.ncbi.nlm.nih.gov/compound/water#section=Top)

APPEARANCE: Colourless liquid (https://pubchem.ncbi.nlm.nih.gov/compound/water#section=Top)
BOILING POINT: 99.974oC (https://pubchem.ncbi.nlm.nih.gov/compound/water#section=Top)
MELTING POINT: 0oC (https://pubchem.ncbi.nlm.nih.gov/compound/water#section=Top)
SPECIFIC GRAVITY/DENSITY: 0.9950 g/cm3 (https://pubchem.ncbi.nlm.nih.gov/compound/water#section=Top)
REGULATORY LISTING
EU GHS CLASSIFICATION: Unclassified

REACH ANNEX XVII Not Controlled
REACH SVHC Not Controlled
EU COSMETICS: Not Controlled
SAFETY SUMMARY
Water is used in the formulation of virtually every type of cosmetic and personal care product. It can be found in lotions, creams, bath
products, cleansing products, deodorants, makeup, moisturizers, oral hygiene products, personal cleanliness products, skin care products,
shampoo, hair conditioners, shaving products, and suntan products. Water is primarily used as a solvent in cosmetics and personal care
products in which it dissolves many of the ingredients that impart skin benefits, such as conditioning agents and cleansing agents. Water is
nontoxic ingredient. Based on dermal route of exposure, very low oral and dermal toxicity and the use of this ingredient in a previously
approved cosmetic products, there are no significant safety concerns relating to this ingredient.
INCI NAME: Sodium Laureth Sulfate

OTHER NAMES: Soudium POE(2) Lauryl Ether Sulfate;
Soudium Diethylene Glycol Lauryl Ether
Sulfate; Sodium Lauryl Ether Sulfate; 2-(2-
dodecyloxyethoxy)Ethyl Sodium Sulfate;
Diethylene Glycol Monododecyl Ether
Sulfate Sodium Salt; Lauristyl Diglycol Ether
Sulfate Sodium Salt; Lauryl Diethylene Glycol
Ether Sulfonate Sodium; Sodium
Dioxyethylenedodecyl Ether Sulfate; Sodium
Lauryl Alcohol Diglycol Ether Sulfate; Sodium
Lauryloxyethoxyethyl Sulfate;
Sodiumlaurylglycolether Sulfate; Natrium-2-
(2-dodecyloxyethoxy)ethylsulfat (German);
Sulfato de sodio y 2-(2-dodeciloxietoxi)etilo
(Spanish); Ssulfate de sodium et de 2-(2-
dodécyloxyethoxy)éthyle (French);
CAS: 3088-31-1
EINEC: 221-416-0
FUNCTION: surfactant
MOLECULAR FORMULA: CH3(CH2)10CH2(OCH2CH2)2OSO3Na

MOLECULAR WEIGHT: -

APPEARANCE: Light yellow liquid
WATER SOLUBILITY:
-
BOILING POINT:
-
MELTING POINT:
-
FLASH POINT:
-
SPECIFIC GRAVITY/DENSITY:
-
REGULATORY LISTING
EU GHS CLASSIFICATION:
-
REACH ANNEX XVII
-
REACH SVHC
-
EU COSMETICS:
-
TOXICOLOGICAL INFORMATION
ADME:
-
ACUTE TOXICITY:
-
REPEATED DOSE:
-
SKIN IRRITATION:
-
EYE IRRITATION:
-
SENSITIZATION:
-
MUTAGENICITY/
-
GENOTOXICITY:
REPROTOXICITY:
-
CARCINOGENICITY:
-
SAFETY SUMMARY
INCI NAME: COCOS NUCIFERA (COCONUT) OIL -

OTHER NAMES: ACIDULATED COCONUT SOAPSTOCK;
COCONUT ACIDULATED SOAPSTOCK;
COCONUT EXTRACT; COCONUT
ABSOLUTE; COCONUT FATTY ACID
TRIGLYCERIDE; COCONUT OIL; COCOS
NUCIFERA OIL; COPRA OIL;
COCOANUT OIL; COCONUT BUTTER;
COCONUT PALM OIL; COPRA OIL;
FREE COCONUT OIL
CAS: 8001-31-8
EINEC: 232-282-8

FUNCTION: FRAGRANCE INGREDIENT; HAIR

CONDITIONING AGENT; SKIN-
CONDITIONING AGENT -
MISCELLANEOUS;SKIN-
CONDITIONING AGENT - OCCLUSIVE;
EMOLLIENT; MASKING; SKIN
CONDITIONING; SOLVENT

MOLECULAR FORMULA: -
MOLECULAR WEIGHT: -
APPEARANCE: Transparent pale yellow liquid
pH: neutral
WATER SOLUBILITY: insoluble
SPECIFIC GRAVITY/DENSITY: -
REGULATORY LISTING
EU GHS CLASSIFICATION: -
REACH ANNEX XVII -
REACH SVHC -
EU COSMETICS: -
ADME: -
ACUTE TOXICITY: -
SKIN IRRITATION: -
EYE IRRITATION: -
SAFETY SUMMARY
Cocos nucifera (coconut) oil, oil from the dried coconut fruit, is composed of 90% saturated triglycerides. It may function as a fragrance
ingredient, hair conditioning agent, or skin-conditioning agent and is reported in 626 cosmetics at concentrations from 0.0001% to 70%. The
related ingredients covered in this assessment are fatty acids, and their hydrogenated forms, corresponding fatty alcohols, simple esters,
and inorganic and sulfated salts of coconut oil. The salts and esters are expected to have similar toxicological profiles as the oil, its
hydrogenated forms, and its constituent fatty acids. Coconut oil and related ingredients are safe as cosmetic ingredients in the practices of
use and concentration described in this safety assessment.
INCI NAME: PHENOXYETHANOL

OTHER NAMES: 2-PhenoxyethanoL; Phenoxyethanol;
Ethylene glycol monophenyl ether;
Phenyl cellosolve; Phenoxytol
CAS: 122-99-6
EINEC: 204-589-7
FUNCTION: •PRESERVATIVE
MOLECULAR FORMULA: C8H10O2 (https://pubchem.ncbi.nlm.nih.gov/compound/2-phenoxyethanol#section=Top)

MOLECULAR WEIGHT: 138.1638 g/mol (https://pubchem.ncbi.nlm.nih.gov/compound/2-phenoxyethanol#section=Top)
APPEARANCE: Clear liquid (HANDBOOK OF PHARMACEUTICAL EXCIPIENTS)
WATER SOLUBILITY: Slightly soluble (HANDBOOK OF PHARMACEUTICAL EXCIPIENTS)
BOILING POINT: >245,2oC (HANDBOOK OF PHARMACEUTICAL EXCIPIENTS)

MELTING POINT: 14oC (HANDBOOK OF PHARMACEUTICAL EXCIPIENTS)

FLASH POINT: 121 (HANDBOOK OF PHARMACEUTICAL EXCIPIENTS)
LOG KOW: 1,16 (HANDBOOK OF PHARMACEUTICAL EXCIPIENTS)
REGULATORY LISTING
EU GHS CLASSIFICATION: H302 Harmful if swallowed, Acute Tox. 4

H319 Causes serious eye irritation, Eye Irrit. 2
EU COSMETICS: V/29 Maximum concentration in ready for use preparation-1
ACUTE TOXICITY: LD50 (Oral, Rat): 1,4 g/kg bw (male), LD50 (Oral, Rat): 1,9 g/kg bw (female) (http://www.beauty-
review.nl/wpcontent/uploads/2014/04/Final-Report-on-the-Safety-Assessment-of-Phenoxyethanol.pdf)
REPEATED DOSE: The no observable adverse effect level (NOAEL) of 80 mg/mg bw was considered based on 90-day study in
rats. (http://ijt.sagepub.com/content/9/2/259.abstract)
SKIN IRRITATION: Phenoxyethanol is irritating to the skin. (http://ijt.sagepub.com/content/9/2/259.abstract)
EYE IRRITATION: Phenoxyethanol is irritating to the eyes. (http://ijt.sagepub.com/content/9/2/259.abstract)
MUTAGENICITY/ Phenoxyethanol was non mutagenic in the Ames test, with and without metabolic activation, and in the
GENOTOXICITY: mouse micronucleus test. (http://ijt.sagepub.com/content/9/2/259.abstract)
REPROTOXICITY: Phenoxyethanol does appear to be a reproductive toxicant in female mice.
(http://ijt.sagepub.com/content/9/2/259.abstract)
TERATOGENICITY: Phenoxyethanol was neither teratogenic, embryotoxic, or fetotoxic at doses which were maternally toxic.
((http://ijt.sagepub.com/content/9/2/259.abstract)
CARCINOGENICITY: Phenoxyethanol is not classifiable as to its carcinogenicity to humans
(http://toxnet.nlm.nih.gov/cgibin/sis/search/a?dbs+hsdb:@term+@DOCNO+5595).
PHOTOTOXICITY: Phenoxyethanol was not phototoxic in clinical studies (http://ijt.sagepub.com/content/9/2/259.abstract)
NOAEL: 80 mg/kg bw (http://www.arb.ca.gov/consprod/regact/2010ra/egpe122996.pdf)
SAFETY SUMMARY
Phenoxyethanol is an antimicrobial preservative used in cosmetics and topical pharmaceutical formulations at a concentration of 0.5–1.0.
Phenoxyethanol produces a local anesthetic effect on the lips, tongue, and other mucous membranes. Possible impurities: phenol. Based on
the dermal route of exposure, level of concentration in the finished product, low toxicity potential, limited solubility in water, and the use of
this ingredient in a previously approved cosmetic products, there are no significant safety concerns relating to this ingredient. This
ingredient is not expected to pose a risk of significant adverse effects in the majority of individuals.
INCI NAME: COCAMIDE MEA -

OTHER NAMES: AMIDES, COCO, N(HYDROXYETHYL), AMIDES, COCO, N-(2-HYDROXYETHYL)-, AMIDES, COCO, N-
(HYDROXYETHYL), COCAMIDE MEA, COCO MONOETHANOLAMIDE, COCO N-(2-HYDROXYETHYL)-
AMIDES, COCONUT FATTY ACID MONOETHANOLAMIDE, COCONUT FATTY ACID,
MONOETHANOLAMIDE; COCONUT OIL FATTY ACID ETHANOLAMIDE; COCONUT OIL FATTY ACID
ETHANOLAMIDE; COCONUT OIL FATTY ACIDS, MONOETHANOLAMIDE; COCONUT OIL
MONOETHANOLAMIDE; COCONUT OIL, MO, COCOYL MONOETHANOLAMINE, EQUEX AEM,
MONOETHANOLAMINE COCONUT ACID AMIDE, N-(2-HYDROXYETHYL) COCO FATTY ACID AMIDE,
and N-(2-HYDROXYETHYL)- AMIDES, COCO
CAS:
EINEC:
FUNCTION: surfactant - foam booster, viscosity increasing agent - aqueous, emulsifying, emulsion stabilising,
foam boosting, surfactant, and viscosity controlling


MOLECULAR FORMULA: -
MOLECULAR WEIGHT: -
APPEARANCE:
BOILING POINT: -
FLASH POINT: -
REGULATORY LISTING
EU GHS CLASSIFICATION:
REACH ANNEX XVII
REACH SVHC -
EU COSMETICS: -
SKIN IRRITATION:
EYE IRRITATION:
SENSITIZATION: -
MUTAGENICITY/ -
GENOTOXICITY:
SAFETY SUMMARY
Cocamide MEA is a compound synthesized from coconut oils and ethanolamine.
INCI NAME: Sodium dodecyl sulfate

OTHER NAMES: Sodium dodecyl sulfate
151-21-3
SODIUM LAURYL SULFATE
Sodium dodecylsulfate
Sodium lauryl sulphate

CAS: 151-21-3,1335-72-4,8012-56-4
EINEC: 205-788-1, 603-752-3, 616-937-9
FUNCTION: detergent

MOLECULAR FORMULA: C12H25O4S.Na or C12H25NaO4S
MOLECULAR WEIGHT: 288.38 g/mol

APPEARANCE: appears as white to pale yellow paste or liquid with a mild odor. Sinks and mixes with water.
WATER SOLUBILITY: Sinks and mixes with water, 100000 mg/L
MELTING POINT: 205.5 °C
DENSITY: greater than 1.1 at 68 °F (USCG, 1999)
REGULATORY LISTING
EU GHS CLASSIFICATION: H228 (32.12%): Flammable solid [Danger Flammable solids]
H302 (95.97%): Harmful if swallowed [Warning Acute toxicity, oral]
H315 (99.83%): Causes skin irritation [Warning Skin corrosion/irritation]
H318 (56.42%): Causes serious eye damage [Danger Serious eye damage/eye irritation]
H319 (37.75%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]
H332 (10.29%): Harmful if inhaled [Warning Acute toxicity, inhalation]
H335 (34.02%): May cause respiratory irritation [Warning Specific target organ toxicity, single exposure;
Respiratory tract irritation]
H412 (26.73%): Harmful to aquatic life with long lasting effects [Hazardous to the aquatic environment,
long-term hazard]
REACH ANNEX XVII -
REACH SVHC -
EU COSMETICS: -
ACUTE TOXICITY:
SKIN IRRITATION: Causes skin irritation
EYE IRRITATION: Causes serious eye irritation
REPEATED DOSE: -
SAFETY SUMMARY
Sodium dodecyl sulfate is an organic sodium salt that is the sodium salt of dodecyl hydrogen sulfate. It has a role as a detergent and a
protein denaturant. It contains a dodecyl sulfate.
INCI NAME: Ethylhexylglycerin

OTHER NAMES: 70445-33-9; 3-[2-
(Ethylhexyl)oxyl]-1,2-
propandiol;
Octoxyglycerin; 3-(2-
ethylhexoxy)propane-1,2-
diol; 3-(2-
ethylhexyloxy)propane-
1,2-diol; 3-(2-
ethylhexyloxy)-1,2-
propanediol
CAS: 70445-33-9
EINEC: 408-080-2
615-116-2
FUNCTION: Preservatives

MOLECULAR FORMULA: C11H24O3
APPEARANCE: -
WATER SOLUBILITY: -

REGULATORY LISTING
EU GHS CLASSIFICATION: H312 (42.86): Harmful in contact with skin [Warning Acute toxicity, dermal]
H318 (100): Causes serious eye damage [Danger Serious eye damage/eye irritation]
H412 (100): Harmful to aquatic life with long lasting effects [Hazardous to the aquatic environment, long-
term hazard]
REACH ANNEX XVII -
REACH SVHC -
EU COSMETICS: -
ACUTE TOXICITY: -
REPEATED DOSE: -
SKIN IRRITATION: -
MUTAGENICITY/ -
GENOTOXICITY:
REPROTOXICITY: -
CARCINOGENICITY: -
SAFETY SUMMARY
INCI NAME: GLYCERIN

OTHER NAMES: Propane-1,2,3-triol; Glycerol; Propane1,2,3-
triol; 1,2,3-Propanetriol; Propane-
1,2,3-triole; Glyceritol; Glycyl ethanol
CAS: 56-81-5
EINEC: 200-289-5
FUNCTION: •DENATURANT
•HAIR CONDITIONING
•HUMECTANT
•MASKING
•ORAL CARE
•PERFUMING
•SKIN PROTECTING
•VISCOSITY CONTROLLING
MOLECULAR FORMULA: C3H8O3 (https://pubchem.ncbi.nlm.nih.gov/compound/glycerol)

MOLECULAR WEIGHT: 92.09382 g/mol (https://pubchem.ncbi.nlm.nih.gov/compound/glycerol)

APPEARANCE: Clear, syrupy liquid (http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)
WATER SOLUBILITY: Miscible (http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)
BOILING POINT: 18oC (http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)
MELTING POINT: 290oC (http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)
SPECIFIC GRAVITY/DENSITY: 1,26 g/cm3 (http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)
LOG KOW: -1,76(http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)
REGULATORY LISTING
EU GHS CLASSIFICATION: Unclassified

ADME: Glycerin is rapidly absorbed in the intestine and the stomach, distributed throughout the extracellular space and renally
excreted. Free glycerin is naturally present in human plasma.
(http://www.cirsafety.org/sites/default/files/Glycer_062014_SLR.pdf)
ACUTE TOXICITY: LD50 (Oral, Rat): 2530-58400 mg/kg, LD50 (Oral, Mouse): 4090-38000 mg/kg, LD50 (Oral, Rabbit): 27000 mg/kg, LD50 (Oral,
Guinea pig): 77500 mg/kg, LD50 (Dermal, Rat): >21900 mg/kg, LD50 (Dermal, Rabbit):
>18700 mg/kg, LD50 (Intraperitoneal, Rat), LD50 (Intraperitoneal, Mouse): 8600-9500 mg/kg, LD50
(Subcutaneous, Rat): 100 mg/kg, LD50 (Subcutaneous, Mouse): 91-100 mg/kg, LD50 (Intravenous, Rat): 5200-
6600 mg/kg, LD50 (Intravenous, Mouse): 4250-6700 mg/kg, LD50 (Intravenous, Rabbit): 53000 mg/kg, LD50 (Oral, Human):
1428 mg/kg. Adverse effects following the oral administration of glycerin (dose not provided) include mild headache,
dizziness, nausea, vomiting, thirst, and diarrhea. (http://www.cirsafety.org/sites/default/files/Glycer_062014_SLR.pdf)
REPEATED DOSE: 1) The no observable adverse effect level (NOAEL) was between 115 and 2300 mg/kg when administered in rats
for 44 days.
2) The no observable effect level (NOEL) in mongrel dogs was 950 mg/kg/day when orally administered in rats for
3 days.
3) The no observable adverse effect level (NOAEL) of 250 mg/mg bw/day was considered based on 50 day-study
in human subjects.
4) The low observed adverse effect level (LOAEL) inhalation was 1000 mg/l for glycerin administered nose only 6
h/day, 5 days/week for 2 weeks in rats, based on local effects on the epithelium of the upper respiratory tract. 5) The no
observable adverse effect level (NOAEL) inhalation was 0.167 mg/l for glycerin administered nose only for 5 h/day, 5
days/week for 13 weeks in rats. (http://www.cirsafety.org/sites/default/files/Glycer_062014_SLR.pdf)
SKIN IRRITATION: Glycerin was not dermally irritating in rabbits at concentrations up to 100%. Glycerin was a mild dermal irritant at 100% in
guinea pigs. Glycerin (10%; 0.05 ml) was slightly irritating in a 48-h occlusive patch test in humans.
(http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)
EYE IRRITATION: Glycerin was not irritating to the eyes of rabbits at concentrations up to 100%. Glycerin (100%) was not irritating when
administered to the eyes of human subjects. (http://www.cirsafety.org/sites/default/files/Glycer_062014_SLR.pdf)
REPROTOXICITY: Glycerin is not expected to be reprotoxic. (http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)

CARCINOGENICITY: Glycerin did not show the carcinogenic potential in animal studies.
(http://www.cirsafety.org/sites/default/files/Glycer_062014_SLR.pdf)
NOAEL: 250 mg/kg bw (http://www.cir-safety.org/sites/default/files/Glycer_062014_SLR.pdf)
SAFETY SUMMARY
Glycerin is reported to be used in many cosmetic products and considered generally recognized as safe (GRAS) by the FDA for food packaging and as a multiple-
purpose food substance. Possible impurities: sodium chloride, polyglycerol, fatty acids and esters, heavy metals, chloride and sulphate residues. Based on
dermal route of exposure, low toxicity potential, level of concentration in the finished product, the previous experience with the similar class of chemicals and
the use of this ingredient in a previously approved cosmetic products, there are no significant safety concerns relating to this ingredient. This ingredient is not
expected to pose a risk of significant adverse effects in the majority of individuals.

INCI NAME: POLYVINYL ALCOHOL

OTHER NAMES: ETHENOL, VINYL ALCOHOL,
HYDROXYETHENE
CAS: 9002-89-5/557-75-5
EINEC: 209-183-3/618-340-9
FUNCTION: film former or a binder
MOLECULAR FORMULA: (C2H3OR)n where R = H or COCH3 or (CH2CHOH-)n or CH2CHOH or C2H4O

APPEARANCE: Odourless, tasteless, translucent, white or cream-coloured granular powder
WATER SOLUBILITY: Solubility in water: good, Slightly soluble in ethanol, but insoluble in other organic solvents
BOILING POINT: 644 °F at 760 mm Hg approximately (NTP, 1992)
MELTING POINT: >200 °C; other melting points: 212-267 °C
pH: -
SPECIFIC GRAVITY/DENSITY: 1.19-1.31 g/cm³
REGULATORY LISTING
EU GHS CLASSIFICATION: H225 (18.52%): Highly Flammable liquid and vapor [Danger Flammable liquids]
H301 (99.07%): Toxic if swallowed [Danger Acute toxicity, oral]
REACH ANNEX XVII
-
REACH SVHC
-
EU COSMETICS:
-
EYE IRRITATION: Low Irritation

SENSITIZATION:
-
REPROTOXICITY:
-
CARCINOGENICITY:
-
SAFETY SUMMARY
Polyvinyl alcohol (PVA) is a colorless amorphous powder. It is used in plastic industry in molding compounds, surface coatings, films resistant
to gasoline, textile sizes and finishing compositions; can be compounded to yield elastomers to be used in manufacturing artificial sponges,
fuel hoses. It is also used in printing inks for plastics and glass, in pharmaceutical finishing, cosmetics, water-soluble film and sheeting.
Pharmaceutic aid (viscosity increasing agent) and opthalmic lubricant. HUMAN EXPOSURE AND TOXICITY: 1.4% neutral solution of PVA with
molecular wt over 100,000/ has been used in eyedrops on human eyes without difficulty. Concentrations as high as 10% also have not been
irritating. A foreign-body type of reaction to an orbital sponge implant of formalinized polyvinyl alcohol resin known as Ivalon has been
described histologically in 1 patient. There is a single report connecting exposure of PVA to human carcinogenesis. Researchers report the
case of a 40-year-old man with hemangiopericytoma of the bladder. This man had a 2-year history of daily dermal exposure to a solution of
PVA in water that did not contain solvents or plasticizers. The use of PVA sponge (Ivalon) prosthetic breast implants was abandoned in the
1950s in favor of silicon. Histology of a 40-year-old PVA implant revealed dramatic structural changes to the prosthesis such as crystallization
and calcification associated with dense fibrotic tissue and some multinucleated giant cells, probably indicating a chronic low grade
inflammatory response to the foreign material. PVA injections are still occasionally called for in the therapeutic embolization of abnormal
tissues. A mild chronic inflammatory response associated with the foreign- body response, infiltration of macrophages, and fibrosis were all
found at autopsy of three cystic fibrosis patients who died 10-28 months following a bronchial embolization procedure. ANIMAL STUDIES: In
eyedrops 1.4% neutral solution of polyvinyl alcohol with molecular weight over 100,000 has been tested repeatedly by application to rabbit
eyes and has been shown to be noninjurious and not to interfere with healing of experimental epithelial wounds. Doses of 2000, 3500 and
5000 mg/kg/day of PVA administered as a dietary admixture to male and female rats for up to 90 days did not result in any adverse,
toxicological effects. Male rats were given sc implants of polyvinyl alcohol (ivalon sponge) of unspecified size into abdominal wall and were
observed for lifespan. 3 Local sarcomas were found in 34 animals still alive at appearance of first local sarcoma at 567 days. In 2 year study
in mice, there was no evidence of carcinogenic activity of polyvinyl alcohol in female mice administered 20 uL of a 25% solution
intravaginally. There were no neoplasms or nonneoplastic lesions considered related to treatment with polyvinyl alcohol. PVA was not
mutagenic with and without rat liver S9 microsomal activation in Salmonella typhimurium strains TA98, TA100 and TA1537. The potential
induction of micronuclei by PVA in bone marrow cells of mice was tested. PVA was administered orally to male and female mice at doses up
to 2000 mg/kg. PVA did not show any evidence of causing chromosome damage or bone marrow cell toxicity. PVA was tested for mutagenic
potential in an in vitro mammalian cell mutation assay, the detection and quantitation of forward mutation in a subline of mouse lymphoma
L5178Y cells, from the heterozygous condition at the thymidine kinase locus (TK +/-) to the thymidine kinase-deficient genotype (TK -/-), in
the presence and absence of S9 mix. PVA was not mutagenic in this in vitro cell mutation assay at concentrations up to 5000 mg/mL.
INCI NAME: Benzalkonium chloride

OTHER NAMES: Biocide Benzalkonium Chloride;Benzalkonium
chloride Manufacturer;8001-54-5
Benzalkonium chloride;Phosphorus
agent;ALKYLDIMETHYLBENZYLAMMONIUM
CHLORIDE;BENZYLDIMETHYLALKYLAMMONIUM
CHLORIDE;BAK;BAC
CAS: 8001-54-5
EINEC: 616-786-9
FUNCTION: Disinfectants; cosmetic;
MOLECULAR FORMULA: C17H30ClN

MOLECULAR WEIGHT: 283.88
APPEARANCE: Clear or white to yellow Viscous Solution, may contain yellow-white fragments
BOILING POINT: >100°C/760mmHg
MELTING POINT: -
SPECIFIC GRAVITY/DENSITY: 0.98
REGULATORY LISTING
EU GHS CLASSIFICATION: H302 Harmful if swallowed. H314 Causes severe skin burns and eye damage. H400 Very toxic to aquatic life.


EYE IRRITATION:
SENSITIZATION:
-
REPROTOXICITY:
-
CARCINOGENICITY:
-
SAFETY SUMMARY
Benzalkonium chloride is a quaternary ammonium mixture of alkyl, dimethyl and benzyl ammonium chlorides.It is an irritant rather than a
sensitizer, but may cause contact dermatitis in nursing and medical personnel. An unusual case was reported in a farm worker who used a
detergent containing benzalkonium chloride to clean the piggery. Is well tolerated in the dilutions normally employed on the skin and
mucous membranes. However, benzalkonium chloride has been associated with adverse effects when used in some pharmaceutical
formulations. Ototoxicity can occur when benzalkonium chloride is applied to the ear and prolonged contact with the skin can occasionally
cause irritation and hypersensitivity. Benzalkonium chloride is also known to cause bronchoconstriction in some asthmatics when used in
nebulizer solutions. Toxicity experiments with rabbits have shown benzalkonium chloride to be harmful to the eye in concentrations higher
than that normally used as a preservative. However, the human eye appears to be less affected than the rabbit eye and many ophthalmic
products have been formulated with benzalkonium chloride 0.01% w/v as the preservative.
Benzalkonium chloride is not suitable for use as a preservative in solutions used for storing and washing hydrophilic soft contact lenses, as
the benzalkonium chloride can bind to the lenses and may later produce ocular toxicity when the lenses are worn. Solutions stronger than
0.03% w/v concentration entering the eye require prompt medical attention.
Local irritation of the throat, esophagus, stomach, and intestine can occur following contact with strong solutions (>0.1% w/v). The fatal oral
dose of benzalkonium chloride in humans is estimated to be 1–3 g. Adverse effects following oral ingestion include vomiting, collapse, and
coma. Toxic doses lead to paralysis of the respiratory muscles, dyspnea, and cyanosis.
LD50 (mouse, oral): 150 mg/kg
LD50 (rat, IP): 14.5 mg/kg
LD50 (rat, IV): 13.9 mg/kg
LD50 (rat, oral): 300 mg/kg
LD50 (rat, skin): 1.42 g/kg
9. UNDESIRABLE EFFECTS AND SERIOUS UNDESIRABLE EFFECTS

The cosmetic product is ready to be placed on the market.
10. INFORMATION OF THE COSMETIC PRODUCT
EFFECT ON SKIN
The product is unlikely to cause systemic dermal toxicity.
EFFECT ON EYES:
May cause temporary eye irritation.

EFFECT ON GASTROINTESTINAL TRACT:
The product is unlikely to cause serious irritation.

EFFECT ON RESPIRATORY TRACT:

It is unlikely that inhalation will be a significant route of exposure.

PART B
COSMETIC PRODUCT SAFETY ASSESSMENT
1. ASSESSMENT CONCLUSION
The data review indicates no significant risk under normal and foreseeable conditions of use. The
product fulfills the required criteria to be marketed in the EU.
2. LABELLED WARNINGS AND INSTRUCTIONS OF USE
There is no need to label any particular warning and instruction of use in accordance with Article 19(1)d
listed in Annexes III and IV of Regulation (EC) No. 1223/2009.
The responsible person is responsible for the content of the label and its compliance with the law. The
responsible person referred to in Article 4 of Regulation (EC) No 1223/2009 shall ensure that the
wording of the claim in relation to cosmetic products is in compliance with the common criteria set
out in the Annex and is consistent with the documentation proving the effect claimed for the cosmetic
product in the product information file referred to in Article 11 of Regulation (EC) No 1223/2009.
3. REASONING
It can be concluded, based on the current knowledge, recommendations from the authorities and
European regulations, toxicological profile and margin of safety of each ingredient in the formulation
(if available), type of the product and level of exposure, compatibility and stability studies, that the
cosmetic product poses no risk to human health when used under normal or reasonably foreseeable
conditions of use.
4. ASSESSOR’S CREDENTIALS AND APPROVAL OF PART B
ASSESSOR'S NAME: Krześniak - Chlasta Marta
EXPERT QUALIFICATIONS: attached to the report on request
Safety Assessor
Intertek Poland


CPSR Soap

Uploaded by

Copyright:

Available Formats

You might also like

CPSR Soap

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CPSR Soap

Uploaded by

Copyright:

Available Formats

Name of the product: Soap flakes Nr TRAPL / Version no.

Intertek Poland Sp. z o.o. Intertek Poland Sp. z o.o.

TYPE OF PRODUCT: Rinse-off

NOMINAL SIZE: 100 g

TYPE OF PACKING: kraft paper one side smoothed

1. QUANTITATIVE AND QUALITATIVE COMPOSITION OF THE COSMETIC PRODUCT

COCAMIDE MEA 68140-00-1 100 4,0 4,0

2. PHYSICAL/CHEMICAL CHARACTERISTICS AND STABILITY OF THE COSMETIC PRODUCT

Intertek Poland Sp. z o.o. Intertek Poland Sp. z o.o.

STABILITY OF THE COSMETIC PRODUCT

PARAMETER METHODOLOGY RESULTS

Total microbial count EP 2.6.12 <1.0x101 CFU / g

Enterobacteria <1.0x101 MPN / g

The number of yeast <1.0x101 CFU / g

The number of molds <1.0x101 CFU / g

The presence of Absent in 10 g

Intertek Poland Sp. z o.o. Intertek Poland Sp. z o.o.

The presence of Clostrid Absent in 10 g

Presence of Salmonella Absent in 10 g

4. IMPURITIES, TRACES, INFORMATION ABOUT THE PACKAGING MATERIAL

Type Result Maximum level

Arsen (As) Not detected 5 ppm

5. NORMAL AND REASONABLY FORESEEABLE USE

Intertek Poland Sp. z o.o. Intertek Poland Sp. z o.o.

6. EXPOSURE TO THE COSMETIC PRODUCT

PRODUCT TYPE: flake soap

TARGET POPULATION: (<16+) and (16+) women and men

ESTIMATED DAILY APPLICATION DOSE [g]: 21.0

DAILY EXPOSURE DOSE [g / day]: 42.0

FREQUENCY OF USE [per day]: 2

TOTAL DAILY EXPOSURE DOSE [mg / kg / day]: 3.5

* BASED ON AN AVERAGE BODY WEIGHT OF 61 KG

LEVEL OF SKIN EXPOSURE [mg / cm2]: 0.12

PLACE OF CONTACT WITH THE HUMAN BODY: hands, body

CONTACT AREA [cm2]: 17 500

APPLICATION METHOD: rinse off product

RETENTION FACTOR: 0.01

INTENDED ROUTES OF EXPOSURE: hands / body

SECONDARY ROUTES OF EXPOSURE: digestive system

7. EXPOSURE TO THE COSMETIC PRODUCT

Intertek Poland Sp. z o.o. Intertek Poland Sp. z o.o.

COCAMIDE MEA 4,0 0,14 - - 0,00480 None

8. TOXICOLOGICAL PROFILE OF THE SUBSTANCES

INCI NAME: AQUA

PHYSICAL AND CHEMICAL PROPERTIES

MOLECULAR FORMULA: H2O (https://pubchem.ncbi.nlm.nih.gov/compound/water#section=Top)

MOLECULAR WEIGHT: 18.01528 g/mol (https://pubchem.ncbi.nlm.nih.gov/compound/water#section=Top)

EU GHS CLASSIFICATION: Unclassified

INCI NAME: Sodium Laureth Sulfate

PHYSICAL AND CHEMICAL PROPERTIES

MOLECULAR FORMULA: CH3(CH2)10CH2(OCH2CH2)2OSO3Na

Intertek Poland Sp. z o.o. Intertek Poland Sp. z o.o.

APPEARANCE: Light yellow liquid

INCI NAME: COCOS NUCIFERA (COCONUT) OIL -

Intertek Poland Sp. z o.o. Intertek Poland Sp. z o.o.

FUNCTION: FRAGRANCE INGREDIENT; HAIR

PHYSICAL AND CHEMICAL PROPERTIES

INCI NAME: PHENOXYETHANOL

PHYSICAL AND CHEMICAL PROPERTIES