Registration Dossier
Registration Dossier
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EC number: 202-612-5 | CAS number: 97-85-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 154.77 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 154.77 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 154.77 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point for a long-term (repeated dose) inhalation systemic DNEL value for workers was the NOAEC value of 7700 mg/m3from a subchronic rat inhalation toxicity study. This value was corrected for duration of exposure and for an increased respiratory volume for light work conditions (see Guidance Document, Chapter R.8.4.2). A first-pass effect was discounted for the purposes of these calculations.
Duration correction: NOAECcorr= NOAECratx (6 hours/d) / (8 hours/d) = 7700 * 0.75 = 5775 mg/m3
Light work correction: (6.7 m3/8 hours / 10 m3/8 hours) = 5775*0.67 = 3869.2 mg/m3
or, NOAECcorr= 3869 mg/m3. Correction factors of 25 are applied (5 for intraspecies, 2.5 for other risks and 2 for subchronic to chronic) for a final DNEL of 154.7 mg/m3.
- AF for differences in duration of exposure:
- 2
- AF for intraspecies differences:
- 5
- AF for remaining uncertainties:
- 2.5
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:
- no hazard identified
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:
- 27.34 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 27.34 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 27.34 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point for a long-term (repeated dose) inhalation systemic DNEL value for general population was the NOAEC value of 7700 mg/m3from a subchronic rat inhalation toxicity study. This value was corrected for daily duration of exposure (6 to 8 hours) and for days of exposure in the week (5 to 7). A first-pass effect was discounted for the purposes of these calculations.
Duration correction: NOAECcorr= NOAECratx (6 hours/d) / (24 hours/d) = 7700 * 0.25 = 1925 mg/m3
Days of the week correction: (5 days/7 days = 0.71) = 1925*0.71 = 1366.75 mg/m3
or, NOAECcorr= 1366.75 mg/m3. Correction factors of 50 are applied (10 for intraspecies, 2.5 for other risks and 2 for subchronic to chronic) for a final DNEL of 27.34 mg/m3.
- AF for differences in duration of exposure:
- 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
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:
- no hazard identified
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:
- 7.86 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEC
- Value:
- 7.86 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7.86 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point for a long-term (repeated dose) inhalation systemic DNEL value for general population was the NOAEC value of 7700 mg/m3from a subchronic rat inhalation toxicity study. This value was corrected for daily duration of exposure (6 to 8 hours) and for days of exposure in the week (5 to 7). A first-pass effect was discounted for the purposes of these calculations.
Duration correction: NOAECcorr= NOAECratx (6 hours/d) / (24 hours/d) = 7700 * 0.25 = 1925 mg/m3
Days of the week correction: (5 days/7 days = 0.71) = 1925*0.71 = 1366.75 mg/m3
or, NOAECcorr= 1366.75 mg/m3. Correction factors of 50 are applied (10 for intraspecies, 2.5 for other risks and 2 for subchronic to chronic) for a final DNEL of 27.34 mg/m3.
The derivation is further corrected for an oral DNEL with the correction of 1.12 for general population (1.15 m3/kg) and an addition of a 4x correction for allometric scaling, for an ultimate Oral DNEL of 7.86 mg/kg.
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
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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