Registration Dossier
Registration Dossier
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EC number: 406-850-2 | CAS number: 133855-98-8 BAS 480 F
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.8 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Parameter Value Unit based on / according to oral NOAEL 0.8 mg/kg bw/day mouse cancer study (critical endpoint: hepatotoxicity; NOEAL for combined sexes) sRVmouse 0.47 m³/(8 h x kg bw) Equation proposed by Alexander et al. 2007 taking into account a mean body weight of 0.04 kg (based on study data) ABSoral-mouse 50 % oral bioavailability agreed upon in EU pesticide registration process ABSinh-human 100 % ECHA guidance sRVhuman 6.7 m³/person (8h) ECHA guidance wRVhuman 10 m³/person (8h) ECHA guidance - AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already included in the modification of the point of departure
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- exhaustive database available
- AF for remaining uncertainties:
- 1
- Justification:
- exhaustive database available
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:
- 0.05 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):
- 87.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.8 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL (mouse) from oral study was converted to a dermal NOAEL by adjusting for absorption:
Mouse oral absorption is assumed to be 50 %, human dermal absorption is assumed to be 10%, which is a worst case estimation, based on the dermal absorption studies. However, as they have not been performed with the pure substance, 10% will be taken forward for risk assessment due to precautionary principle.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- default factor for mice
- AF for other interspecies differences:
- 2.5
- Justification:
- default for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default for worker
- AF for the quality of the whole database:
- 1
- Justification:
- exhaustive database available
- AF for remaining uncertainties:
- 1
- Justification:
- exhaustive database available
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:
- 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
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:
- no hazard identified
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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