Registration Dossier
Registration Dossier
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EC number: 800-003-4 | CAS number: 1415316-96-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 270 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 136 mg/m³
- Explanation for the modification of the dose descriptor starting point:
corrected for exposure duration (6h => 8h), higher respiration rate during activity (6.7m³ => 10m³ in 8h)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
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:
- 1.94 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 582 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL => NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic => chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The LOAEL from the 90 -day dermal study was selected as starting point for the systemic long term DNEL. For comparison, the same calculation (excluding the factor of 3 for extrapolating from LOAEL to NOAEL) was performed using the NOAEL of app. 236mg/kg from the EOGRTS as starting point. This results in a very similar DNEL of 2.36mg/kg.
Though effects on reproductive parameters were observed in the EOGRTS, their relevance for human health are still unclear. Nevertheless, they occur at higher concentrations than the effects on blood, liver and kidneys, leading to a NOAEL of app. 360mg/kg. Consequently, the derived DNEL based on effects on blood, liver and kidney is also protective against any potential developmental effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.96 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 270 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 48.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
corrected for exposure duration (6h => 24h), exposure days (5 days => 7 days)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default factor for consumer
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
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:
- 0.97 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- LOAEL
- Value:
- 582 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL => NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic => chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default for consumers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 236 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic => chronic (test duration in EOGRTS was app. 90 days)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
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 LOAEL from the 90 -day dermal study was selected as starting point for the systemic long term DNEL. For comparison, the same calculation (excluding the factor of 3 for extrapolating from LOAEL to NOAEL) was performed using the NOAEL of app. 236mg/kg from the EOGRTS as starting point. This results in a very similar DNEL of 1.2mg/kg.
Though effects on reproductive parameters were observed in the EOGRTS, their relevance for human health are still unclear. Nevertheless, they occur at higher concentrations than the effects on blood, liver and kidneys, leading to a NOAEL of app. 360mg/kg. Consequently, the derived DNEL based on effects on blood, liver and kidney is also protective against any potential developmental effects.
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