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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-448-9 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 149.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Since no long-term inhalation toxicity data are available the oral NOAEL must be converted to an inhalation value to use as the starting point. Using the formula for workers in Figure R.8-3 of Chapter R.8 (p.27) and the oral NOAEL of 85 mg/kg, the resulting inhalation NOAEC would be 149.9 mg/m3. Because this conversion includes interspecies exposure duration differences, no allometric scaling assessment factor is required.
- AF for dose response relationship:
- 1
- Justification:
- no other uncertainties
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic/toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- DNEL derived for workers
- AF for the quality of the whole database:
- 1
- Justification:
- the database is complete
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:
- 85 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on data from a dermal absorption study of the read across substance (C12 LAS homologue) in isolated human epidermis (Howes 1975) that indicated < 0.065% of the applied dose penetrated the skin in 48 hours, 1% dermal absorption is conservatively assumed. The dermal NOAEL is therefore 8500 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- no other uncertainties
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic/toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- DNEL for workers
- AF for the quality of the whole database:
- 1
- Justification:
- the data base is sufficient
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:
- 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:
- 1.5 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 73.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Since no long-term inhalation toxicity data are available the oral NOAEL must be converted to an inhalation value to use as the starting point. Using the formula for the general population in Figure R.8-3 of Chapter R.8 (p.27) and the oral NOAEL of 85 mg/kg, the resulting inhalation NOAEC would be 73.9 mg/m3. Because this conversion includes interspecies exposure duration differences, no allometric scaling assessment factor is required.
- AF for dose response relationship:
- 1
- Justification:
- no other uncertainties
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic/toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- DNEL for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- the data base is sufficient
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:
- 42.5 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on data from a dermal absorption study of the read across substance (C12 LAS homologue) in isolated human epidermis (Howes 1975) that indicated < 0.065% of the applied dose penetrated the skin in 48 hours, 1% dermal absorption is conservatively assumed. The dermal NOAEL is therefore 8500 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- no other uncertainties
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic/toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- DNEL for general population
- AF for the quality of the whole database:
- 1
- Justification:
- the data base is sufficient
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:
- 0.425 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:
- 85 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point oral value is taken from the 9-month repeated dose toxicity study, which resulted in a NOAEL of 85 mg/kg bw/d. No corrections for route-to-route extrapolation are necessary.
- AF for dose response relationship:
- 1
- Justification:
- no other uncertainties
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic/toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- DNEL for general population
- AF for the quality of the whole database:
- 1
- Justification:
- the data base is sufficient
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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.
