Registration Dossier
Registration Dossier
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EC number: 212-092-1 | CAS number: 762-12-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49.4 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 234.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction factor for differences in bioavailability (ABS), oral vs. inhalation absorption: 0.5
Correction factor for differences in respiratory volume (SRV): 2.63 (1/0.38 m3/kg)
Correction factor for light activity at work (WORKER): 0.67 (6.7 m3/10 m3)
Correction for differences between human and experimental exposure conditions (EXPCOND): 1.4 (5 days/7 days)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49.4 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
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:
- 140 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Correction factor for differences in bioavailability (ABS), oral vs. dermal absorption: 10
Dermal absorption is supposed very low for several reasons.
1) The substance is dry and practically non soluble in water (0.12 mg/l, if water solubility is < 1 mg/l, dermal uptake is likely to be low); the experimental log Kow is 8.4; therefore very few of the substance goes from the stratum corneum to the epidermidis.
2) The molecular weight is 342.5 g/mol, so not really in favour of dermal absorption (below 100: in favour of dermal absorption, above 500, not in favour of absorption)
3) the substance is not a skin irritant, therefore no increase of skin absorption is expected.
Therefore, dermal absorption can be reasonably estimated to be lower than 10%. No data is available on absorption by oral route. It is therefore assumed that oral absorption
factor is 100 %.
Correction for differences between human and experimental exposure conditions (EXPCOND): 1.4 (5
days/7 days)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- 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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction factor for differences in bioavailability (ABS), oral vs. inhalation absorption: 0.5
Correction factor for differences in respiratory volume (SRV): 0.87 (1/1.15 m3/kg)
Correction for differences between human and experimental exposure conditions (EXPCOND): 1
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for remaining uncertainties:
- 1
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:
- 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:
- 50 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Correction factor for differences in bioavailability (ABS), oral vs. dermal absorption: 10 (see workers)
Correction for differences between human and experimental exposure conditions (EXPCOND): 1
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- 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:
- 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- 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
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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