Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.58 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
264.47 mg/m³
Explanation for the modification of the dose descriptor starting point:
meets 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
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
chronic lifetime study duration
AF for interspecies differences (allometric scaling):
1
Justification:
as per ECHA guidance R.8
AF for other interspecies differences:
2.5
Justification:
pharmacodynamic
AF for intraspecies differences:
5
Justification:
individual variability
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2
Justification:
read-across from structural analogue
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31.74 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):
0.33
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:
meets 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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
meets 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
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
chronic lifetime duration
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
pharmacodynamic
AF for intraspecies differences:
5
Justification:
individual variability
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2
Justification:
read-across from structural analogue
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not undertaken
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
chronic lifetime duration
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
pharmacodynamic
AF for intraspecies differences:
10
Justification:
individual variability
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2
Justification:
read-across from structural analogue
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The monomer is not available to the general population. The chronic systemic oral DNEL is calculated for consideration of exposure of man via the environment.