Registration Dossier
Registration Dossier
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EC number: 411-370-1 | CAS number: 82857-68-9 GM 102 E
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 98 µg/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):
- 225
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 22 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrected inhalatory NOAEC = Oral NOAEL x 1 / sRVrat x Abs (oral, rat) / Abs (inhal, human) x sRVhuman / wRV
- AF for dose response relationship:
- 1
- Justification:
- Use of reliable NOAEL as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required due to route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Use of a Klimisch 1 reliable study
- AF for remaining uncertainties:
- 3
- Justification:
- Based on the severity of effects (lower number of pups delivered)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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:
- 28 µg/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):
- 900
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Corrected dermal NOAEL = Oral NOAEL x Abs (oral, rat) / Abs (dermal, human) [both absorption considered 100% in the absence of specific TK data]
- AF for dose response relationship:
- 1
- Justification:
- Use of reliable NOAEL as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Use of a Klimisch 1 reliable study
- AF for remaining uncertainties:
- 3
- Justification:
- Based on the severity of effects (lower number of pups delivered)
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:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
General population is irrelevant based on the industrial use of the substance and the absence of direct exposure of consumers.
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