Registration Dossier
Registration Dossier
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EC number: 931-371-5 | CAS number: 171171-80-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic 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
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:
- 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- 100% absorption assumed, worst case
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from sub-chronic to chronic exposure as per R8 guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default extrapolation from rat to man as per R8 guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factors to cover remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Assessment factor for worker population as per R8 guidance
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
A worst case scenario was adopted at the route to route extrapolation stage (100% absorption via dermal route). Default assessment factors were applied as stipulated in Table R.8.6 of ECHA Guidance on information requirements and chemical safety assessment Chapter R8: Characterisation of dose [concentration]-response for human health.
General Population - Hazard via inhalation route
Systemic 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
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:
- 0.5 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:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- 100 % absorption is assumed via both routes in both species.
- AF for differences in duration of exposure:
- 2
- Justification:
- Assessment factor for extrapolation from sub-chronic to chronic exposure as per R8 guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Assessment factor for allometric scaling from rat to man as per R8 guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Assessment factor for remaining differences as per R8 guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population as per R8 guidance
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:
- 0.5 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:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not required
- AF for differences in duration of exposure:
- 2
- Justification:
- Assessment factor for extrapolation from sub-chronic to chronic exposure as per R8 guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Assessment factor for allometric scaling from rat to man as per R8 guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Assessment factor for remaining interspecies differences as per R8 guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population variation
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
A worst case scenario was adopted at the route to route extrapolation stage. Default assessment factors were applied as stipulated in Table R.8.6 of ECHA Guidance on information requirements and chemical safety assessment Chapter R8: Characterisation of dose [concentration]-response for human health.
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.
