Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 205-275-2 | CAS number: 137-05-3
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 173.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation study technically not feasible. Due to immediate polymerization and graduate degradation of the polymer, a low absorption rate is assumed for all routes.
- AF for dose response relationship:
- 1
- Justification:
- Good quality NOAEL is the basis for the DNEL derivation (ECHA REACH Guidance), no adverse effects were observed at the highest dose tested
- AF for differences in duration of exposure:
- 3
- Justification:
- ECHA REACH Guidance, subchronic to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already considered in the conversion of the oral NOAEL into an inhalation NOAEC (ECHA REACH Guidance)
- AF for other interspecies differences:
- 1
- Justification:
- Already considered in the conversion of the oral NOAEL into an inhalation NOAEC (ECHA REACH Guidance)
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Three studies are available that consistently point to a low repeated dose toxicity (no adverse effects at hightest dose)
- AF for remaining uncertainties:
- 1
- Justification:
- Three studies are available that consistently point to a low repeated dose toxicity (no adverse effects at hightest dose)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Evaluation of the German MAK commission
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The substance immediately polymerizes upon contact with skin and falls off after some time. Therefore, a very low absorption is assumed after dermal exposure. As worst case calculation, a dermal absorption of 100% compared to the oral absorption is assumed.
- AF for dose response relationship:
- 1
- Justification:
- Good quality NOAEL is the basis for the DNEL derivation (ECHA REACH Guidance), no adverse effects were observed at the highest dose tested
- AF for differences in duration of exposure:
- 3
- Justification:
- ECHA REACH Guidance, subchronic to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance (worst case assumption, no awareness of possible other interspecies differences)
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Three studies are available that consistently point to a low repeated dose toxicity (no adverse effects at hightest dose)
- AF for remaining uncertainties:
- 1
- Justification:
- Three studies are available that consistently point to a low repeated dose toxicity (no adverse effects at hightest dose)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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