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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
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:
- 88.2 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No study on long-term inhalation toxicity available.
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance (no effect observed up to the limit dose of 1000 mg/kg bw)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance (subchronic to chronic exposure)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA Guidance (allometric scaling is not necessary for the inhalation route)
- AF for other interspecies differences:
- 1
- Justification:
- No additional interspecies default factor is necesarry (due to the substance characteristic no interspecies differences are to be expected. This is supported by a generally low toxicity profile.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidance (default factor for workers)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance (default value for good quality of database (GLP), also taking into account completeness and consistency)
- AF for remaining uncertainties:
- 2
- Justification:
- ECHA Guidance, route-to-route extrapolation (oral to inhalation)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
This endponit is coverd by long term inhalation exposure assessment.
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:
- 12.5 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):
- 80
- 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
- Explanation for the modification of the dose descriptor starting point:
No study on long-term dermal toxicity available.
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance (no effect observed up to the limit dose of 1000 mg/kg bw)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance (subchronic to chronic exposure)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Guidance (allometric scaling rat to human)
- AF for other interspecies differences:
- 1
- Justification:
- No additional interspecies default factor is necesarry (due to the substance characteristic no interspecies differences are to be expected. This is supported by a generally low toxicity profile
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidance (default value for workers)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance (default value for good quality (GLP) of database, also taking into account completeness and consistency)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Guidance
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:
- 43.47 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.56 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not necessary for the inhalation route
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 12.5 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):
- 80
- 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:
- ECHA Guidance (default value)
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- ECHA Guidance (default value)
- AF for intraspecies differences:
- 10
- Justification:
- ECHA Guidance (default value)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance (default value for good quality (GLP) of database, also taking into account completeness and consistency)
- AF for remaining uncertainties:
- 1
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:
- no hazard 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
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.
