Registration Dossier
Registration Dossier
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EC number: - | CAS number: 2156594-77-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.8 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 280 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 346 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the inhalation route available. Therefore, the worker-DNEL long-term for inhalation route - systemic is derived from the NOAEL of 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAECcorr. is calculated as follows:
- standard respiratory volume rat = 0.38 m³/kg/8h
- standard respiratory volume human = 6.7 m³/8h
- worker respiratory volume = 10 m³/8h
- absorption (oral, rat) = 50 % (default)
- absorption (inhalative, human) = 100 % (default)
--> modified dose descriptor (corrected inhalatory NOAEC) = 280 mg/kg bw/day * (1/0.38 m³/kg/d) * (6.7 m³ (8h)/10 m³ (8h)) * (0.5/1) * (7 exposure days/week; rat/5 exposure days/week; worker) = 346 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:
- 2
- Justification:
- ECHA REACH Guidance (subchronic --> chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- 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:
- 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:
- 19.6 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 280 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 960 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 worker-DNEL long-term for dermal route - systemic is derived from the NOAEL of 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAELcorr. is calculated as follows:
- absorption (oral, rat) = 50 % (default)
- absorption (dermal, human) = 10 % (assumed as worst case)
--> modified dose descriptor (corrected dermal NOAEL) = 280 mg/kg bw/day * (0.5/0.1) * (7 exposure days/week; rat/5 exposure days/week; worker) = 1960 mg/kg bw/day
- 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:
- 2
- Justification:
- ECHA REACH Guidance (subchronic --> 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
- 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:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.4 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 280 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 122 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the inhalation route available. Therefore, the general population-DNEL long-term for inhalation route - systemic is derived from the NOAEL of 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAECcorr. is calculated as follows:
- standard respiratory volume rat = 1.15 m³/kg/24h
- absorption (oral, rat) = 50 % (default)
- absorption (inhalative, human) = 100 % (default)
--> modified dose descriptor (corrected inhalatory NOAEC) = 280 mg/kg bw/day * (1/1.15 m³/kg/d) * (0.5/1) = 122 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:
- 2
- Justification:
- ECHA REACH Guidance (subchronic --> chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- 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:
- 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:
- 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 280 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 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 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAELcorr. is calculated as follows:
- absorption (oral, rat) = 50 % (default)
- absorption (dermal, human) = 10 % (assumed as worst case)
--> modified dose descriptor (corrected dermal NOAEL) = 280 mg/kg bw/day * (0.5/0.1) = 1400 mg/kg bw/day
- 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:
- 2
- Justification:
- ECHA REACH Guidance (subchronic --> 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
- 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:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.4 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:
- 280 mg/kg bw/day
- 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:
- 2
- Justification:
- ECHA REACH Guidance (subchronic --> 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
- 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:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
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