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ADVIA Diff TIMEPAC United Kingdom DXDCM 09017fe980214d01-1623132860261
ADVIA Diff TIMEPAC United Kingdom DXDCM 09017fe980214d01-1623132860261
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 1/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 2/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
ADVIA® PEROX 2
2,2' -oxybisethanol
Supplemental label : ADVIA® PEROX 1 Not applicable.
elements ADVIA® PEROX 2 Not applicable.
ADVIA® PEROX 3 Not applicable.
ADVIA® PEROX SHEATH Not applicable.
Annex XVII - Restrictions : ADVIA® PEROX 1 Restricted to professional users.
on the manufacture, ADVIA® PEROX 2 Not applicable.
placing on the market and ADVIA® PEROX 3 Not applicable.
use of certain dangerous ADVIA® PEROX SHEATH Not applicable.
substances, mixtures and
articles
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 3/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
ADVIA® PEROX 2
2,2' -oxybisethanol EC: 203-872-2 ≥90 Acute Tox. 4, H302 [1] [2]
CAS: 111-46-6
Index: 603-140-00-6
See Section 16 for
the full text of the H
statements declared
above.
There are no additional ingredients present which, within the current knowledge of the supplier and in the
concentrations applicable, are classified as hazardous to health or the environment, are PBTs, vPvBs or Substances
of equivalent concern, or have been assigned a workplace exposure limit and hence require reporting in this section.
Type
[1] Substance classified with a health or environmental hazard
[2] Substance with a workplace exposure limit
[3] Substance meets the criteria for PBT according to Regulation (EC) No. 1907/2006, Annex XIII
[4] Substance meets the criteria for vPvB according to Regulation (EC) No. 1907/2006, Annex XIII
[5] Substance of equivalent concern
[6] Additional disclosure due to company policy
Occupational exposure limits, if available, are listed in Section 8.
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 4/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 5/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 6/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
4.2 Most important symptoms and effects, both acute and delayed
Over-exposure signs/symptoms
Eye contact : ADVIA® PEROX 1 Adverse symptoms may include the
following:
pain or irritation
watering
redness
ADVIA® PEROX 2 No specific data.
ADVIA® PEROX 3 No specific data.
ADVIA® PEROX SHEATH No specific data.
Inhalation : ADVIA® PEROX 1 Adverse symptoms may include the
following:
respiratory tract irritation
coughing
ADVIA® PEROX 2 No specific data.
ADVIA® PEROX 3 No specific data.
ADVIA® PEROX SHEATH No specific data.
Skin contact : ADVIA® PEROX 1 Adverse symptoms may include the
following:
irritation
redness
ADVIA® PEROX 2 No specific data.
ADVIA® PEROX 3 No specific data.
ADVIA® PEROX SHEATH No specific data.
Ingestion : ADVIA® PEROX 1 No specific data.
ADVIA® PEROX 2 No specific data.
ADVIA® PEROX 3 No specific data.
ADVIA® PEROX SHEATH No specific data.
4.3 Indication of any immediate medical attention and special treatment needed
Notes to physician : ADVIA® PEROX 1 Treat symptomatically. Contact poison
treatment specialist immediately if large
quantities have been ingested or inhaled.
ADVIA® PEROX 2 Treat symptomatically. Contact poison
treatment specialist immediately if large
quantities have been ingested or inhaled.
ADVIA® PEROX 3 Treat symptomatically. Contact poison
treatment specialist immediately if large
quantities have been ingested or inhaled.
ADVIA® PEROX SHEATH Treat symptomatically. Contact poison
treatment specialist immediately if large
quantities have been ingested or inhaled.
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 7/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
6.2 Environmental : Avoid dispersal of spilt material and runoff and contact with soil, waterways, drains
precautions and sewers. Inform the relevant authorities if the product has caused
environmental pollution (sewers, waterways, soil or air).
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 8/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
ADVIA® PEROX 2
2,2' -oxybisethanol EH40/2005 WELs (United Kingdom (UK), 8/2018).
TWA: 101 mg/m³ 8 hours.
TWA: 23 ppm 8 hours.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace
procedures atmosphere or biological monitoring may be required to determine the effectiveness
of the ventilation or other control measures and/or the necessity to use respiratory
protective equipment. Reference should be made to monitoring standards, such as
the following: European Standard EN 689 (Workplace atmospheres - Guidance for
the assessment of exposure by inhalation to chemical agents for comparison with
limit values and measurement strategy) European Standard EN 14042 (Workplace
atmospheres - Guide for the application and use of procedures for the assessment
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 9/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
PNECs
No PNECs available
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 10/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 12/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 13/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
ADVIA® PEROX 2
2,2' -oxybisethanol LD50 Dermal Rabbit 11890 mg/kg -
LD50 Oral Rat 12000 mg/kg -
Conclusion/Summary : ADVIA® PEROX 1 Not available.
ADVIA® PEROX 2 Not available.
ADVIA® PEROX 3 Not available.
ADVIA® PEROX SHEATH Not available.
Irritation/Corrosion
Product/ingredient name Result Species Score Exposure Observation
ADVIA® PEROX 1
formaldehyde Eyes - Mild irritant Human - 6 minutes 1 -
parts per
million
Eyes - Severe irritant Rabbit - 24 hours 750 -
Micrograms
Eyes - Severe irritant Rabbit - 750 -
Micrograms
Skin - Mild irritant Human - 72 hours 150 -
Micrograms
Intermittent
Skin - Severe irritant Human - 0.01 Percent -
Skin - Mild irritant Rabbit - 540 -
milligrams
Skin - Moderate irritant Rabbit - 24 hours 50 -
milligrams
Skin - Severe irritant Rabbit - 24 hours 2 -
milligrams
ADVIA® PEROX 2
2,2' -oxybisethanol Eyes - Mild irritant Rabbit - 50 milligrams -
Skin - Mild irritant Human - 72 hours 112 -
milligrams
Intermittent
Skin - Mild irritant Rabbit - 500 -
milligrams
Conclusion/Summary
Skin : ADVIA® PEROX 1 Not available.
ADVIA® PEROX 2 Not available.
ADVIA® PEROX 3 Not available.
ADVIA® PEROX SHEATH Not available.
Eyes : ADVIA® PEROX 1 Not available.
ADVIA® PEROX 2 Not available.
ADVIA® PEROX 3 Not available.
ADVIA® PEROX SHEATH Not available.
Respiratory : ADVIA® PEROX 1 Not available.
ADVIA® PEROX 2 Not available.
ADVIA® PEROX 3 Not available.
ADVIA® PEROX SHEATH Not available.
Sensitisation
Conclusion/Summary
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 14/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 15/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Delayed and immediate effects as well as chronic effects from short and long-term exposure
Short term exposure
Potential immediate : ADVIA® PEROX 1 Not available.
effects ADVIA® PEROX 2 Not available.
ADVIA® PEROX 3 Not available.
ADVIA® PEROX SHEATH Not available.
Potential delayed effects : ADVIA® PEROX 1 Not available.
ADVIA® PEROX 2 Not available.
ADVIA® PEROX 3 Not available.
ADVIA® PEROX SHEATH Not available.
Long term exposure
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 16/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 17/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
ADVIA® PEROX 2
2,2' -oxybisethanol Acute LC50 75200000 μg/l Fresh water Fish - Pimephales promelas 96 hours
Conclusion/Summary : ADVIA® PEROX 1 Not available.
ADVIA® PEROX 2 Not available.
ADVIA® PEROX 3 Not available.
ADVIA® PEROX SHEATH Not available.
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 18/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
12.6 Other adverse effects : ADVIA® PEROX 1 No known significant effects or critical
hazards.
ADVIA® PEROX 2 No known significant effects or critical
hazards.
ADVIA® PEROX 3 No known significant effects or critical
hazards.
ADVIA® PEROX SHEATH No known significant effects or critical
hazards.
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 19/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 20/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 21/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
14.6 Special precautions for : ADVIA® PEROX 1 Transport within user’s premises:
user always transport in closed containers
that are upright and secure. Ensure that
persons transporting the product know
what to do in the event of an accident or
spillage.
ADVIA® PEROX 2 Transport within user’s premises:
always transport in closed containers
that are upright and secure. Ensure that
persons transporting the product know
what to do in the event of an accident or
spillage.
ADVIA® PEROX 3 Transport within user’s premises:
always transport in closed containers
that are upright and secure. Ensure that
persons transporting the product know
what to do in the event of an accident or
spillage.
ADVIA® PEROX SHEATH Transport within user’s premises:
always transport in closed containers
that are upright and secure. Ensure that
persons transporting the product know
what to do in the event of an accident or
spillage.
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 22/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
International regulations
Inventory list
Europe inventory : ADVIA® PEROX 1 All components are listed or exempted.
ADVIA® PEROX 2 All components are listed or exempted.
ADVIA® PEROX 3 All components are listed or exempted.
ADVIA® PEROX SHEATH Not determined.
15.2 Chemical safety : This product contains substances for which Chemical Safety Assessments are still
assessment required.
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 23/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
ADVIA® PEROX 2
Acute Tox. 4, H302 Calculation method
Full text of abbreviated H statements
ADVIA® PEROX 1
H301 Toxic if swallowed.
H302 Harmful if swallowed.
H311 Toxic in contact with skin.
H314 Causes severe skin burns and eye damage.
H315 Causes skin irritation.
H317 May cause an allergic skin reaction.
H319 Causes serious eye irritation.
H330 Fatal if inhaled.
H332 Harmful if inhaled.
H335 May cause respiratory irritation.
H341 Suspected of causing genetic defects.
H350 May cause cancer.
ADVIA® PEROX 2
H302 Harmful if swallowed.
Full text of classifications [CLP/GHS]
ADVIA® PEROX 1
Acute Tox. 2, H330 ACUTE TOXICITY (inhalation) - Category 2
Acute Tox. 3, H301 ACUTE TOXICITY (oral) - Category 3
Acute Tox. 3, H311 ACUTE TOXICITY (dermal) - Category 3
Acute Tox. 4, H302 ACUTE TOXICITY (oral) - Category 4
Acute Tox. 4, H332 ACUTE TOXICITY (inhalation) - Category 4
Carc. 1B, H350 CARCINOGENICITY - Category 1B
Eye Irrit. 2, H319 SERIOUS EYE DAMAGE/EYE IRRITATION - Category 2
Muta. 2, H341 GERM CELL MUTAGENICITY - Category 2
Skin Corr. 1B, H314 SKIN CORROSION/IRRITATION - Category 1B
Skin Irrit. 2, H315 SKIN CORROSION/IRRITATION - Category 2
Skin Sens. 1, H317 SKIN SENSITISATION - Category 1
STOT SE 3, H335 SPECIFIC TARGET ORGAN TOXICITY - SINGLE EXPOSURE
(Respiratory tract irritation) - Category 3
ADVIA® PEROX 2
Acute Tox. 4, H302 ACUTE TOXICITY (oral) - Category 4
Training advice : Provide workers with adequate training to assure that chemicals are handled safely
in accordance with national and community legislation.
Date of printing : 6/7/2021
Date of issue/ Date of : 6/7/2021
revision
Date of previous issue : 12/13/2016
Version : 2
Indicates information that has changed from previously issued version.
Notice to reader
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 24/25
Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II, as amended by Commission Regulation (EU)
2015/830 - United Kingdom (UK)
ADVIA® Diff TIMEPAC
Date of issue/Date of revision : 6/7/2021 Date of previous issue : 12/13/2016 Version :2 25/25