Registration Dossier
Registration Dossier
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EC number: 202-852-0 | CAS number: 100-43-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 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):
- 37.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13.23 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Fails criteria of Guidelines on Route-to-Route Extrapolation of Toxicity Data when Assessing Health Risks of Chemicals, by the Intergovernmental Group on Health Risks from Chemicals (IGHRC, 2006) and Rennen, MAJ, Bouwman T, Wilshut A, Bessems JGM and DeHeer, C. 2004. Oral-to-inhalation route extrapolation in occupational health risk assessment: A critical assessment. Regulatory Toxicol Pharmacol 39: 5-11. It is not valid to use the results as calculated below.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- as per ECHA 2010
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic (remainder)
- AF for intraspecies differences:
- 5
- Justification:
- individual variability
- AF for the quality of the whole database:
- 1.5
- Justification:
- read-across to structural analogue
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.05 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.35 mg/m³
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:
- 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:
- 0.13 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:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Fails criteria of Guidelines on Route-to-Route Extrapolation of Toxicity Data when Assessing Health Risks of Chemicals, by the Intergovernmental Group on Health Risks from Chemicals (IGHRC, 2006) and Rennen, MAJ, Bouwman T, Wilshut A, Bessems JGM and DeHeer, C. 2004. Oral-to-inhalation route extrapolation in occupational health risk assessment: A critical assessment. Regulatory Toxicol Pharmacol 39: 5-11.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic (remainder)
- AF for intraspecies differences:
- 5
- Justification:
- individual variability
- AF for the quality of the whole database:
- 1.5
- Justification:
- read-across from structural analogue
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.39 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):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.13 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Fails criteria of Guidelines on Route-to-Route Extrapolation of Toxicity Data when Assessing Health Risks of Chemicals, by the Intergovernmental Group on Health Risks from Chemicals (IGHRC, 2006) and Rennen, MAJ, Bouwman T, Wilshut A, Bessems JGM and DeHeer, C. 2004. Oral-to-inhalation route extrapolation in occupational health risk assessment: A critical assessment. Regulatory Toxicol Pharmacol 39: 5-11.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Route-to-route extrapolation of DNELs is invalid for this substance, as it demonstrates portal-of-entry toxicity, according to the Guidelines on Route-to-Route Extrapolation of Toxicity Data when Assessing Health Risks of Chemicals, by the Intergovernmental Group on Health Risks from Chemicals (IGHRC, 2006) and published papers.
No. |
Criterion |
4VP meets criterion? |
1 |
The available toxicity data are considered adequate and reliable |
Yes. |
2 |
Critical effects for the routes under consideration are systemic, and absorption and expression of toxicity are not influenced by possible local effects. |
Critical effect: Decreased weight gain (Vlaovic 1984). Yes. Local effect: corrosion in non-glandular stomach: No. |
3 |
The considered toxic effect is independent of the route of exposure |
Systemic: Decreased weight gain: Yes. Local: stomach irritation: No. |
4 |
The absorption efficiency is the same between routes or the difference is known and can be quantified. |
No info available, but defaults are available |
5 |
The half-life of the chemical is long. |
Unknown |
6 |
Hepatic first-pass effects are minimal, and the substance is not broken down to a substantial extent in the stomach or upper GI tract. |
Unknown first-pass effects, |
7 |
No significant biotransformation occurs by intestinal microflora or pulmonary macrophages. |
Unknown |
8 |
The chemical is relatively soluble in body fluids |
Yes. (is water-soluble) |
From IGHRC, 2006, and Rennen, et al., 2004
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)
- Most sensitive endpoint:
- acute toxicity
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.067 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no extrapolation
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic (remainder)
- AF for intraspecies differences:
- 10
- Justification:
- individual variability
- AF for the quality of the whole database:
- 1.5
- Justification:
- read-across from structural analogue
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
No hazards anticipated for the general population for this substance, a monomer which is reacted into a stable polymer.
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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