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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-842-3 | 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:
- 66 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:
- 940 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 828.65 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalatory NOAEC = (940 mg/kg/day) x ( 1/(0.38 m3/kg/d)) x (50%/100%) x (6.7 m3/10 m3)
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- The only effect found in the repeated dose toxicity study was the tissue lesion in the stomach that was considered as irritating local effect on the direct contact site.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already considered
- 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:
- All studies of high quality.
- AF for remaining uncertainties:
- 1
- Justification:
- The applied read-across is considered reliable and robust
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
DNEL related information
- DNEL derivation method:
- other: Messinger H, 2014.Regulatory Toxicology and Pharmacology 68 (2014) 317–324
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18.8 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:
- 940 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 940 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification needed.
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- The only effect found in the repeated dose toxicity study was the tissue lesion in the stomach that was considered as irritating local effect on the direct contact site.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default
- 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:
- All studies of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- The applied read-across is considered reliable and robust
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 940 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 408 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalatory NOAEC = (940 mg/kg/day) x ( 1/(1.15 m3/kg/d)) x (50%/100%)
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- The only effect found in the repeated dose toxicity study was the tissue lesion in the stomach that was considered as irritating local effect on the direct contact tissue
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already considered
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- All studies of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- The applied read-across is considered reliable and robust
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
DNEL related information
- DNEL derivation method:
- other: Messinger H, 2014.Regulatory Toxicology and Pharmacology 68 (2014) 317–324
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.4 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:
- 940 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 940 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification needed
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- The only effect found in the repeated dose toxicity study was the tissue lesion in the stomach that was considered as irritating local effect on the direct contact site
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- All studies of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- The applied read-across is considered reliable and robust
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.4 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:
- 940 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 940 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification needed
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect up to the highest dose
- AF for differences in duration of exposure:
- 1
- Justification:
- The only effect found in the repeated dose toxicity study was the tissue lesion in the stomach that was considered as irritating local effect on the direct contact site.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- All studies of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- The applied read-across is considered reliable and robust
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
The registration substance is used as ingredient for cosmetics and personal care products. No other use is known for the registrant.
The safety assessment for use as cosmetic ingredient is out of scope of REACH and therefore no safety assessment is to be performed for the consumer.
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.
