Registration Dossier
Registration Dossier
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EC number: 201-807-2 | CAS number: 88-18-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.47 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):
- 60
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Available data do not suggest a pronounced difference between oral and inhalation route. Due to a lack of experimental data the NOAEC (corr) was derived including ECHAs recommended absorption rates for exposure via the oral (50%) and inhalation (100%) route.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from sub-acute to chronic (default)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default (inhalation)
- AF for other interspecies differences:
- 2
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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)
DNEL related information
Workers - 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:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The hazard assessment is mainly based on the corrosive properties of the substance. Systemic hazard by the dermal route has not been assessed as local effects are considered more relevant to determine the appropriate risk management measures.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.36 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):
- 120
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.48 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Available data do not suggest a pronounced difference between oral and inhalation route. Due to a lack of experimental data the NOAEC (corr) was derived including ECHAs recommended absorption rates for exposure via the oral (50%) and inhalation (100%) route.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from sub-acute to chronic (default)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default (inhalation)
- AF for other interspecies differences:
- 2
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 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:
- 100 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from sub-acute to chronic (default)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
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:
- medium hazard (no threshold derived)
Additional information - General Population
The hazard assessment is mainly based on the corrosive properties of the substance. Systemic hazard by the dermal route has not been assessed as local effects are considered more relevant to determine the appropriate risk management measures.
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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