Registration Dossier
Registration Dossier
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EC number: 931-276-9 | CAS number: 114959-46-5
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:
- Oral to dermal extrapolation assumed to be 100%, so factor applied is 1. Absorption through skin will be lower than that via the gastrointestinal tract, hence this is worst case.
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from sub-chronic 90d study (on read-across substance) to chronic exposure, as per guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- extrapolation from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences, as per guidance R8, after allometric scaling
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker population applied
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 for oral to dermal exposure. 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:
- Oral to dermal extrapolation assumes 100% absorption as worst case (though true absorption is likely to be much lower), factor used is 1.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from sub-chronic study to chronic exposure in man
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation from rat to man (allometric scaling)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining differences (other than allometric scaling)
- AF for intraspecies differences:
- 10
- Justification:
- Default value as per REACH guidance R8 for general population
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
- 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:
- Extrapolation from sub-chronic study to chronic exposure in man
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation from rat to man (allometric scaling)
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences, default value as per R8 REACH guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population, as per R8, REACH guidance
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 for dermal DNEL derivation. 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.
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