Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 423-900-9 | CAS number: 10009-20-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 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):
- 187.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 215 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 379 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 215 mg/kg bw/day obtained in the oral gavage 28d-repeated dose toxicity study in rats (0, 215 and 1000 mg/kg bw) was chosen as dose descriptor starting point.
For workers:
Corrected inhalatory NOAEC = oralNOAEL x 1/sRVanimal x ABS oral / ABS inhalation
The standard respiratory volume (sRV) for the 8 h exposure is 0.38 m³/kg bw for rats and 6.7 m³ (per
person) in humans. The default 8-h respiratory volume of a worker is 10 m³ taking increased activity into
account. The inhalatory absorption is regarded to be equivalent to the oral absorption.
This results in the following equation:
Corrected inhalatory NOAEC = 215 mg/kg bw/d x 1/0.38 m³/kg bw x 6.7 m³ / 10 m3 = 379 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
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:
- 0.29 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):
- 750
- Dose descriptor starting point:
- NOAEL
- Value:
- 215 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 215 mg/kg bw/day obtained in the oral gavage 28d-repeated dose toxicity study in rats (0, 215 and 1000 mg/kg bw) was chosen as dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
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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