Registration Dossier
Registration Dossier
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EC number: 617-441-5 | CAS number: 83121-18-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.18 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):
- 15
- Dose descriptor starting point:
- LOAEL
- Value:
- 2.1 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 2.69 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Applying the standard values taken from ECHA Guidance R.8, the following apply:
respiratory volume rat: 2.2 L/h, body weight 25 g (values for females represent worst-case approach)
This can be converted to 0.704 m3/kg bw in 8h
Taking into consideration the oral and inhalation absorption values specified in IUCLID section 7.1, a corrected LOAEC of 2.69 mg/m3 is derived.
- AF for dose response relationship:
- 3
- Justification:
- Default for use of LOAEL as starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for use of chronic study as starting point
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default for derivation of inhalation DNEL
- AF for other interspecies differences:
- 1
- Justification:
- Data on multiple species available, show that mouse is clearly the most sensitive species and LOAEL is worst-case POD for risk assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default according to ECHA guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default for use of OECD guideline and GLP study
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:
- 36 µg/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):
- 105
- Dose descriptor starting point:
- LOAEL
- Value:
- 2.1 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 3.78 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Taking into consideration the oral and dermal absorption rates (as specified in IUCLID section 7.1) and using the oral NOAEL of 2.1 mg/kg bw/d as starting point, a corrected NOAEL of 3.78 mg/kg bw/d can be derived.
- AF for dose response relationship:
- 3
- Justification:
- Default for use of LOAEL as starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for use of chronic study as starting point
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- Default for mouse - human extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- Data on multiple species available, show that mouse is clearly the most sensitive species and LOAEL is worst-case POD for risk assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default according to ECHA Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default for use of OECD guideline and GLP study as starting point
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:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- other toxicological threshold
- Value:
- 10 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
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
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