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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-704-1 | CAS number: 538-75-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.212 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2.645 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Based on carcinogenicity study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Mouse
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.034 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 87.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A worst case scenario is assumed in which the absorption rate from dermal route is considered to be 100%.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Carcinogenicity study
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- Mouse
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
As basis for DNEL derivation, the result from a 27-week
carcinogenicity study in female p53 haploinsufficient mice via dermal
route was used (NTP protocol, GLP study). This NOAEL of 3 mg/kg bw/d was
selected as a worst case scenario, as it is the lowest available value
and from the longest available study for this substance. Also as a
worst-case scenario, dermal absorption was assumed to be 100%. All
calculations were performed according to ECHA guidance documents.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.052 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.304 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Carcinogenicity study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default
- 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
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 0.017 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 175
- Dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Carcinogenicity study
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- Mice
- 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
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.017 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 175
- Dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 1
- Justification:
- Carcinogenicity study
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- Mice
- 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
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
As basis for DNEL derivation, the result from a 27-week carcinogenicity study in female p53 haploinsufficient mice via dermal route was used (NTP protocol, GLP study). This NOAEL of 3 mg/kg bw/d was selected as a worst case scenario, as it is the lowest available value and from the longest available study for this substance. Also as a worst-case scenario, dermal absorption was assumed to be 100%. All calculations were performed according to ECHA guidance documents.
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.
