Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 267-023-8 | CAS number: 67762-55-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 882 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 1000 mg/kg/day x (1/0.38) x (50% oral abs /100% inhalation abs) x (6.7/10)= 882 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox; 90 day study has Klimisch score of 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor for subchronic to chronic study extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already taken into account during the correction of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- 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:
- 10 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor for subchronic to chronic study extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for extrapolating toxicokinetics from Rat to Human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- 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
The substance was not considered mutagenic in studies that were adequately conducted. In a reliable OECD 408 gavage study in the rat the NOAEL was established at the limit dose (1000 mg/kg bw) with no adverse effects for either repeat dose or reproductive or developmental toxicity in a prenatal study (OECD 414). No adverse effects were observed at the limit dose in the acute oral or dermal toxicity studies. No local tolerance issues were identified from skin irritation, skin sensitisation, or eye irritation studies.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 1000 mg/kg/day x (1/1.15) x (50% oral abs /100% inhalation abs) = 435 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor for subchronic to chronic study extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already taken into account during the correction of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for tonnage
- AF for remaining uncertainties:
- 1
- Justification:
- 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:
- 5 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor for subchronic to chronic study extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for extrapolating toxicokinetics from Rat to Human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for tonnage
- AF for remaining uncertainties:
- 1
- Justification:
- 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:
- 5 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor for subchronic to chronic study extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for extrapolating toxicokinetics from Rat to Human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for tonnage
- AF for remaining uncertainties:
- 1
- Justification:
- 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
The substance was not considered mutagenic in studies that were adequately conducted. In a reliable OECD 408 gavage study in the rat the NOAEL was established at the limit dose (1000 mg/kg bw) with no adverse effects for either repeat dose or reproductive or developmental toxicity in a prenatal study (OECD 414). No adverse effects were observed at the limit dose in the acute oral or dermal toxicity studies. No local tolerance issues were identified from skin irritation, skin sensitisation, or eye irritation studies.
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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