Registration Dossier
Registration Dossier
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EC number: 229-114-0 | CAS number: 6413-10-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.5 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 762 mg/m³
- Explanation for the modification of the dose descriptor starting point:
1000 mg/kg/day x 1/0.38 x 6.7/10 x 1 (oral absorption rat 100%/inhalation absorption human 100%)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- default value - subacute to chronic
- Justification:
- not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.3 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
1000 mg/kg/day x 4 (oral absorption rat 100%/inhalation absorption human 25%)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- default value - subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The substance has low acute toxicity following oral administration or dermal application, with LD50 values greater than 5000 mg/kg bw. It is not irritating either for the skin or eyes and has no sensitising potential. On this basis no acute DNELs, either for systemic or local effects were considered necessary.
Based on a complete set of in-vitro studies including gene mutation in bacterial and mammalian cells and a chromosome aberration test, all negative, it is concluded that the substance has no genotoxic properties.
In a fully compliant OECD 422 study, neither adverse systemic effects nor adverse effects on reproduction, fertility and development of offspring were noted up to an including the limit dose of 1000 mg/kg bw/day. This endpoint as been chosen as the most appropriate for setting long-term systemic DNELs.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869 mg/m³
- Explanation for the modification of the dose descriptor starting point:
1000 mg/kg/day x 1/1.15 x 1 (oral absorption rat 100%/inhalation absorption human 100%)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- default value - subacute to chronic
- Justification:
- not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- default value - 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:
- 6.7 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
1000 mg/kg/day x 4 (oral absorption rat 100%/inhalation absorption human 25%)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- default value - subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- default value - 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
same oral absorption in rat and human
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- default value - subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value - rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- default value - 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The same endpoint used for setting long-term systemic DNELs for workers has been used for the general population. The increased AF for intraspecies sensitivity is considered to be sufficiently protective, given the low toxicity of the substance.
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.
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