Registration Dossier
Registration Dossier
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EC number: 225-935-3 | CAS number: 5160-02-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.29 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 32.42 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 28.58 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr.= 32.42 mg/kg bw/day * (1 / (0.38 m³/kg/day)) * (0.5 / 1) * (6.7 m³ / 10 m³) = 28.58 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining uncertainties
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
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:
- 0.65 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 32.42 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 32.42 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL(corr.) = 32.42 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
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
1. Identification of relevant dose descriptor
In an in-utero and life time study performed in rat , the substance did not cause mortalities, toxicity to reproduction and development or any adverse effects. The NOAEL is considered to be 32.42 mg/kg bw/d.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
3. Application of assessment factors
Allometric scaling: rat to human = 4
Remaining uncertainties: interspecies differences = 2.5
Intraspecies factor: worker = 5, general population = 10
Exposure duration chronic to chronic: 1
Quality of data base: 1
Dose response: 1
4. Daily exposure
Worker: exposed for 8h
General population: exposed for 24h
Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.56 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 32.42 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 14.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr.= 32.42 mg/kg bw/day * (1 / (1.15 m³/kg/day)) * (0.5 / 1) = 14.1 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining uncertainties
- AF for intraspecies differences:
- 10
- Justification:
- consumer
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
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:
- 0.32 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 32.42 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 32.42 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL(corr.) = 32.42 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining uncertainties
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
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:
- 0.32 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 32.42 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 32.42 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining uncertainties
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
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
1. Identification of relevant dose descriptor
In an in-utero and life time study performed in rat , the substance did not cause mortalities, toxicity to reproduction and development or any adverse effects. The NOAEL is considered to be 32.42 mg/kg bw/d.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
3. Application of assessment factors
Allometric scaling: rat to human = 4
Remaining uncertainties: interspecies differences = 2.5
Intraspecies factor: worker = 5, general population = 10
Exposure duration chronic to chronic: 1
Quality of data base: 1
Dose response: 1
4. Daily exposure
Worker: exposed for 8h
General population: exposed for 24h
Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008
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