Registration Dossier
Registration Dossier
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EC number: 308-662-5 | CAS number: 98171-53-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 265 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL used as starting point was based on effects of the combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (BASF, 2018) and taking into consideration the previously dose-range study. The NOAEL was corrected in terms of bioavailability (50% oral absorption / 100% inhalation absorption), differences in respiratory volumes and a correction for expected light work in workers compared to resting animals.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as the surrogate to the NAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic durtation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for allometric scaling already considered within dose discriptor modification NOAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- no substance-specific data are available, default for other interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- standard default factor for threshold effects in worker
- AF for the quality of the whole database:
- 1
- Justification:
- no potential remaining uncertainties in the derived DNEL
- AF for remaining uncertainties:
- 1
- Justification:
- no potential remaining uncertainties in the derived DNEL
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 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL used as starting point was based on effects of the combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (BASF, 2018) and taking into consideration the previouslydose-range study. A correction was not necassary as the bioavailability is considered to be 100% for both the dermal and the oral route.
In a conservative approach, differences between the experimental conditions and the conditions for workers (working days per week) are considered to be minimal.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as the surrogate to the NAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic durtation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default rat allometric factor for scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- no substance-specific data are available, default for other interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- standard default factor for threshold effects in worker
- AF for the quality of the whole database:
- 1
- Justification:
- no potential remaining uncertainties in the derived DNEL
- AF for remaining uncertainties:
- 1
- Justification:
- no potential remaining uncertainties in the derived DNEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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