Registration Dossier
Registration Dossier
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EC number: 600-735-2 | CAS number: 106276-79-3
Toxicological Summary
Administrative data
Workers - 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:
- other toxicological threshold
- Value:
- 1.25 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 1.25 mg/m³
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.7 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no valid experimental data on repeated exposure by the dermal route available. Therefore, the worker-DNEL long-term for dermal route - systemic is derived from the NOAEL of 1000 mg/kg bw/day, obtained in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with a strucutral analogue in Wistar rats. The NOAELcorr. is calculated
as follows:
- absorption (oral, rat) = absorption (dermal, human)
--> modified dose descriptor (corrected dermal NOAEL) = 1000 mg/kg bw/day *(absorption (oral, rat) / absorption (dermal, human)) * (7 exposure days/week; rat / 5 exposure days/week; worker) = 1400 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance (subacute --> chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance (rat --> human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance (good/standard quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.7 mg/kg bw/day
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no experimental data on repeated exposure by the dermal route available. Therefore, the general population-DNEL long-term for dermal route - systemic is derived from the NOAEL of 1000 mg/kg bw/day,
obtained in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with a strucutral analogue in Wistar rats. The NOAELcorr. is calculated
as follows:
- absorption (oral, rat) = absorption (dermal, human)
--> modified dose descriptor (corrected dermal NOAEL) = 1000 mg/kg bw/day *(absorption (oral, rat) / absorption (dermal, human)) = 1000 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance (subacute --> chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance (rat --> human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance (good/standard quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 mg/kg bw/day
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 1000 mg/kg bw/day, obtained in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in Wistar rats, is used as dose descriptor starting point. As this as an study with oral substance administration, a modification of the starting point is not necessary.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance (subacute --> chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance (rat -->human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance (good/standard quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 mg/kg bw/day
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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