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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 458-880-0 | 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:
- 14.1 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:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 352 mg/m³
- Explanation for the modification of the dose descriptor starting point:
well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for dose response relationship:
- 1
- Justification:
- well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- dose unit is mg/m^3, thus no allometric scaling needed
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- for workers
- AF for the quality of the whole database:
- 1
- Justification:
- well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for remaining uncertainties:
- 1
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 42.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
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:
- 2 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for dose response relationship:
- 1
- Justification:
- well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat vs. man
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- for workers
- AF for the quality of the whole database:
- 1
- Justification:
- well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for remaining uncertainties:
- 1
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 3.5 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:
- 173 mg/m³
- Explanation for the modification of the dose descriptor starting point:
well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for dose response relationship:
- 1
- Justification:
- well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- dose unit is mg/m^3; thus no allometric scaling is needed
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- for general population
- AF for the quality of the whole database:
- 1
- Justification:
- well performed guideline conform oral repeat dose study of the read-accross substance NA-11
- AF for remaining uncertainties:
- 1
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 000 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- well performed guideline conform acute inhalation toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- dose unit is mg/m^3; thus no allometric scaling is needed
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- for general population
- AF for the quality of the whole database:
- 1
- Justification:
- well performed guideline conform acute inhalation toxicity study
- AF for remaining uncertainties:
- 1
- Justification:
- no uncertainties
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:
- 1 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:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
well performed guideline conform oral repeat dose study performed with the read-accross substance NA-11
- AF for dose response relationship:
- 1
- Justification:
- well performed guideline conform oral repeat dose study
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat vs. man
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- for general population
- AF for the quality of the whole database:
- 1
- Justification:
- well performed guideline conform oral repeat dose study
- AF for remaining uncertainties:
- 1
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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:
- 200 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- well performed guideline conform oral repeat dose study
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat vs. man
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- for general population
- AF for the quality of the whole database:
- 1
- Justification:
- well performed guideline conform oral repeat dose study
- AF for remaining uncertainties:
- 1
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
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.
