Registration Dossier
Registration Dossier
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EC number: 269-682-7 | CAS number: 68309-95-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - 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
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The substance is of low acute toxicity following oral and dermal exposure. The substance is not irritating either to the skin or to the eyes, and does not possess any skin sensitisation potential. On these bases no acute DNELs are required.
Data evaluating the genotoxic potential of the substance allow the conclusion that the substance is not genotoxic. A fully compliant OECD 422 study, under the worst condition of oral gavage, set the parental systemic as well as the reproductive and developmental toxicity NOEL at 1000 mg/kg bw/day, the limit dose, because treatment did not affect any of the parameters, including FOBs and motor activity assessments, as well as reproductive performence and development of offspring up to day 4 of lactation. This endpoint is considered appropriate to calculate long-term DNELs for workers exposure. An additional assessment factor of 2 was applied because data on reproductive and developmental toxicity are limited to the above-mentioned OECD 422 study and no data on chronic toxicity are available.
Taken together all the available toxicological information suggests that the substance should be at most minimally absorbed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The general population is not expected to be exposed to the substance.
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