Registration Dossier
Registration Dossier
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EC number: 203-121-9 | CAS number: 103-54-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.35 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 352.63 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL = 200 mg/kg bw/d from a sub-acute oral repeated dose / reprotox tox study in rats.
--> 200 mg/kg bw/d / 0.38 m3/kg bw * 6.7 m3/ 10 m3
NOAEC = 352.63 mg/m3
- AF for dose response relationship:
- 2
- Justification:
- default value for route-to-route extrapolation according to R.8.4.2.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- default value according to R.8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.667 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No specific information on dermal absorption taken into account.
This approach starts from the assumption that dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH standard AF for intraspecies differences to workers
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties 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
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:
- 0.58 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 173.91 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL = 200 mg/kg bw/d from a sub-acute oral repeated dose tox study in rats.
--> 200 mg/kg bw/d / 1.15 m3/kg bw
NOAEC = 173.91 mg/m3
- AF for dose response relationship:
- 2
- Justification:
- default value for route-to-route extrapolation according to R.8.4.2.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- differences not related to calorimetric differences
- AF for intraspecies differences:
- 10
- Justification:
- default value according to R.8.4.3.1
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.333 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No specific information on dermal absorption taken into account.
This approach starts from the assumption that dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH default AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties 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:
- 0.333 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral absorption by rat and human are assumed to be equal.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH standard AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
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 test item is not eye irritant.
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