Registration Dossier
Registration Dossier
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EC number: 939-009-8 | CAS number: -
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.4 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
- Dose descriptor starting point:
- NOAEC
- Value:
- 765 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 384 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification for exposure: 6/8 (Rat Exposure condition (6h) / Worker Exposure condition (8 h)
Modification for respiratory volume: 6.7/10 (respiratory rate difference under standard conditions and under conditions of light activity for 8 hours)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
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:
- 0.418 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 89.5 mg/kg bw/day
- Value:
- 125.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL generation plugin)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- DNEL (Derived No Effect Level)
- Value:
- 2.74 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
- Dose descriptor starting point:
- NOAEC
- Value:
- 765 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 137 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification for exposure: (6/24)*(5/7) (Rat Exposure condition (6h – 5/7 days) / General population Exposure condition (24 h – 7/7 days)
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Default
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.149 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 89.5 mg/kg bw/day
- Value:
- 89.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL generation plugin)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.149 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 89.5 mg/kg bw/day
- Value:
- 89.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL generation plugin)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
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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