Registration Dossier
Registration Dossier
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EC number: 254-179-7 | CAS number: 38888-98-1
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:
- 0.3 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- toxicokinetic properties allow a route to route extrapolation
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- not required, chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required due to corrected starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- worker, default value ECHA
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.1 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):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4.83 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The resoprtion after oral and dermal application is considered to comparable.
- AF for dose response relationship:
- 1
- Justification:
- not required
- AF for differences in duration of exposure:
- 1
- Justification:
- not required, chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat -> man
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- worker, default value ECHA
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low 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:
- 0.08 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:
- 2.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- toxicokinetic properties allow a route to route
- AF for dose response relationship:
- 1
- Justification:
- not required
- AF for differences in duration of exposure:
- 1
- Justification:
- not required
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required due to corrected starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- default value ECHA
- AF for intraspecies differences:
- 10
- Justification:
- default value for general pouplation
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4.83 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- toxicokinetic properties allow a route to route
- AF for dose response relationship:
- 1
- Justification:
- not required
- AF for differences in duration of exposure:
- 1
- Justification:
- not required
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat -> man
- AF for other interspecies differences:
- 2.5
- Justification:
- default value ECHA
- AF for intraspecies differences:
- 10
- Justification:
- default value general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4.83 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not required
- AF for dose response relationship:
- 1
- Justification:
- not required
- AF for differences in duration of exposure:
- 1
- Justification:
- not required
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat -> man
- AF for other interspecies differences:
- 2.5
- Justification:
- default value ECHA
- AF for intraspecies differences:
- 10
- Justification:
- default value 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
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