Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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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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