Registration Dossier
Registration Dossier
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EC number: 424-820-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Sub-acute (28 day): NOAEL local = 50 mg/kg bw/day; NOAEL systemic >/= 150 mg/kg bw/day (OECD 407).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available information comprises an adequate and reliable 28 day study (Klimish score 2).
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test was conducted in accordance to EU method B.7 and OECD guideline 407. Oral administration of the test material under conditions of this study elicited no signs of systemic toxicity. Treatment-related adverse effects were limited to local stomach irritation observed in the high dose (150 mg/kg) males and females which was reversible after a 14 day recovery period. There were no adverse effects with respect to clinical signs, body weights, body weight changes, food consumption, clinical parameters, or organ weights. Based on the microscopic changes observed in the stomachs at the high dose level, a No Observable Effect Level (NOEL) was established at 50 mg/kg of the test material in both males and females for local effects. Excluding microscopic effects in the forestomach attributed to the irritant nature of the test material, a systemic NOAEL in males and female rats would be 150 mg/kg.
Justification for classification or non-classification
Oral administration of the test material under conditions of this study (acc. to OECD 407) elicited no signs of systemic toxicity. Treatment-related adverse effects were limited to local stomach irritation observed in the high dose (150 mg/kg) males and females which was reversible after a 14 day recovery period. There were no adverse effects with respect to clinical signs, body weights, body weight changes, food consumption, clinical parameters, or organ weights. It is therefore considered that the registration material EC 424-820-7 does not require a STOT-repeated exposure classification based on the available data.
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