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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-061-8 | CAS number: 77-83-8
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.63 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.26 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 44.08 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
- Value:
- 441 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 88.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Workers - 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor:
- NOAEC
- Value:
- 441 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The DNELs for long-term systemic toxicity of the substance via the inhalation and dermal route were derived by route-to-route extrapolation from the sub-chronic oral NOEL of 500 mg/kg bw/day established in a dietary study with rats. Since the substance is a strong skin sensitizer, workers handling the neat substance or mixtures containing higher concentrations of the substance shall apply appropriate dermal protection to avoid dermal exposure to the substance.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.17 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 4
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.43 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor:
- NOAEC
- Value:
- 217 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 4
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.74 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEC
- Value:
- 217 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 4
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.13 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 160
- Dose descriptor:
- NOAEC
- Value:
- 217 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 4
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEC
- Value:
- 217 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 4
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Default ECHA assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The DNELs for long-term systemic toxicity of the substance via the inhalation and dermal route were derived by route-to-route extrapolation from the sub-chronic oral NOEL of 500 mg/kg bw/day established in a dietary study with rats.
Since the substance is a strong skin sensitizer, there may be a hazard. However, fragranced end-products meant for end-use by the general public generally contain low amounts of the substance, which lowers the likelihood that skin sensitisation may appear.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
