Registration Dossier
Registration Dossier
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EC number: 222-321-7 | CAS number: 3425-61-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 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):
- 75
- Dose descriptor starting point:
- NOAEC
- Value:
- 337 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 225.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction factor for light activity at work (WORKER): 0.67 (6.7 m3/10 m3)
Correction for differences between human and experimental exposure conditions (EXPCOND): 1 (as the DNEL is based on a NOAEC > 337 mg/m3, this correction (6h/8h) was not applied, considering that the NOAEC will not lower than 337 mg/m3 after a 8 -hour exposure)
- AF for dose response relationship:
- 1
- Justification:
- Not needed
- AF for differences in duration of exposure:
- 6
- Justification:
- Point of departure: 28-day study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not needed for an inhalation dose
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor
- AF for intraspecies differences:
- 5
- Justification:
- default factor
- AF for the quality of the whole database:
- 1
- Justification:
- Not needed
- AF for remaining uncertainties:
- 1
- Justification:
- Not needed
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Justification:
- No irritation of the respiratory tract was observed in a 28-day inhalation toxicity study performed according to the OECD guideline no. 412.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.16 mg/kg bw/day
- 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):
- 300
- Dose descriptor starting point:
- NOAEC
- Value:
- 337 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 48 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL is calculated from the NOAEC of 337 mg/m3 of the 28-day inhalation toxicity described above. Using a daily respiration rate of 0.29 m3/kg in rats for a 6-hour exposure, and a default absorption of 50% by the inhalation route, the internal dose is 48 mg/kg bw/d. Assuming a value of 100% for the default dermal absorption, the dermal NAEL is 48 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- default factor
- AF for differences in duration of exposure:
- 6
- Justification:
- default factor
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor
- AF for intraspecies differences:
- 5
- Justification:
- default factor
- AF for the quality of the whole database:
- 1
- Justification:
- not needed
- AF for remaining uncertainties:
- 1
- Justification:
- not needed
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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 but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
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