Registration Dossier
Registration Dossier
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EC number: 236-740-8 | CAS number: 13472-08-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.99 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 24.68 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 10 mg/kg/day from an OECD 408 oral study with rats on a read-across substance was used as the starting point.
Indication is that the substance is well absorbed following oral route. Further the substance is a crystalline solid with a relatively large mean particle size of 43.5 microns. Therefore, it can be expected that after inhalation exposure, particles will mainly be deposited high in bronchial tract, and removed from the upper respiratory tract by the mucociliary elevator. With subsequent swallowing, this results to no principal difference in absorption compared to oral route.
An additional correction from 7d/w dosing to 5d/w occupational exposures has been subsequently applied.
The corrected 8 hr inhalation NOAEC for workers is NOAEL(10 mg/kg) * 1/0.38 * 6.7/10(light exercise) * 7/5(correction dosing 7days/wk) = 24.68 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECHA guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECHA guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- In accordance with ECHA guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- In accordance with ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- In accordance with ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- In accordance with ECHA guidance
- AF for remaining uncertainties:
- 1
- Justification:
- In accordance with ECHA guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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:
- 467 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 46 667 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 10 mg/kg/day from an OECD 408 oral study with rats on a read-across substance (AIBN)was used. A dermal penetration study is available on the read-across substance (AIBN). This resulted to a penetrated amount of 0.01% of applied dose on human skin. QSARs indicate that the dermal absorption rate of the target substance AMBN is 3 times higher than that of AIBN. A dermal absorption of 3*0.01% = 0.03% was taken to correct the starting point of 10 mg/kg/day.
An additional correction from 7d/w dosing to 5d/w occupational exposures has been subsequently applied.The corrected 8 hr dermal NOAEL for workers is NOAEL(10 mg/kg/0.03%) * 7/5 (correction dosing 7days/wk) = 46667 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECHA guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECHA guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- In accordance with ECHA guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- In accordance with ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- In accordance with ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- In accordance with ECHA guidance
- AF for remaining uncertainties:
- 1
- Justification:
- In accordance with ECHA 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
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:
- 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
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
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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