Registration Dossier
Registration Dossier
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EC number: 203-492-7 | CAS number: 107-46-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 53.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 335 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC: Modification for experimental exposure duration (6 h in study to 8 h in workers): 0.75. Modification for respiratory volume (rat to human): 6.7/10. Therefore the corrected NOAEC for repeat dose effects via the inhalation route is: 2657*0.75*(6.7/10) = 1335 mg/ m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- repeat dose NOAEC from 2-generation reproductive toxicity study, animals dosed for at least 90-days (therefore sub-chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 333 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on a reliable in vitro dermal absorption study, 0.023% of the dose was absorbed through the skin. For the purposes of the DNEL calculation, a conservative figure of 1% absorption is used. The following correction was made to the NOAEL: human absorption = 1%, therefore modified NOAEL = 1000*(100/1) = 100000 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (dermal rat to dermal human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 664 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC: Modification for experimental exposure duration (6 h in study to 24 h in General Population): 6/24 = 0.25. Therefore the corrected NOAEC for repeat dose effects via the inhalation route is: 2657*0.25 = 664 mg/ m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- repeat dose NOAEC from 2-generation reproductive toxicity study, animals dosed for at least 90-days (therefore sub-chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- DNEL (Derived No Effect Level)
- Value:
- 167 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on a reliable in vitro dermal absorption study, 0.023% of the dose was absorbed through the skin. for the purposes of the DNEL calculation, a conservative figure of 1% absorption is used. The following correction was made to the NOAEL: human absorption = 1%, therefore modified NOAEL = 1000*(100/1) = 100000 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (dermal rat to dermal human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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:
- 0.27 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 160 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No corrections were made to the NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to oral human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default (guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default (no remaining uncertainties)
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
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