Registration Dossier
Registration Dossier
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EC number: 807-840-4 | CAS number: 64896-70-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 141 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 526 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see Discussion
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for systemic effects
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- See Discussion
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric value (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for systemic effects
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
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
The starting point for the derivation of the DNELs is the NOAEL obtained in rat in an oral 13-week repeated toxicity study: NOAEL = 2000 mg/kg bw/d.
When calculating DNELs according to Chapter R.8 of Guidance on Information Requirements and Chemical Safety Assessment (2008) the overall AFs for oral and dermal repeated dose toxicity are 200 (for general population) and 100 (for workers). This is established by taking into account an interspecies factor of 10 (4 for metabolic rate differences × 2.5 for remaining differences), an intraspecies factor of 10 (for general population) and 5 (for workers), and a further factor of 2 to allow for subchronic to chronic extrapolation. The overall AFs for inhalation repeated dose toxicity which should be applied to the corrected NOAECs (2,000 mg/kg bw/day/0.38 m3/kg/day × 6.7 m3/10 m3 for worker and 2,000 mg/kg bw/day/1.15 m3/kg/day for general population) are 25 (for workers) and 50 (for general population) respectively. This is established by taking into account an interspecies factor of 2.5 (for remaining differences), an intraspecies factor of 5 (for workers) and 10 (for general population), and a further factor of 2 to allow for subchronic to chronic extrapolation.
As no hazard was identified for acute toxicity and local effects, no DNELs were calculated.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 34 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 739 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- See Discussion
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- See Discussion
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric value (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
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:
- 10 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric value (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
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
The starting point for the derivation of the DNELs is the NOAEL obtained in rat in an oral 13-week repeated toxicity study: NOAEL = 2000 mg/kg bw/d.
When calculating DNELs according to Chapter R.8 of Guidance on Information Requirements and Chemical Safety Assessment (2008) the overall AFs for oral and dermal repeated dose toxicity are 200 (for general population) and 100 (for workers). This is established by taking into account an interspecies factor of 10 (4 for metabolic rate differences × 2.5 for remaining differences), an intraspecies factor of 10 (for general population) and 5 (for workers), and a further factor of 2 to allow for subchronic to chronic extrapolation. The overall AFs for inhalation repeated dose toxicity which should be applied to the corrected NOAECs (2,000 mg/kg bw/day/0.38 m3/kg/day × 6.7 m3/10 m3 for worker and 2,000 mg/kg bw/day/1.15 m3/kg/day for general population) are 25 (for workers) and 50 (for general population) respectively. This is established by taking into account an interspecies factor of 2.5 (for remaining differences), an intraspecies factor of 5 (for workers) and 10 (for general population), and a further factor of 2 to allow for subchronic to chronic extrapolation.
As no hazard was identified for acute toxicity and local effects, no DNELs were calculated.
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