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Administrative data

Description of key information

The oral LD50 was determined to be >5000 mg/kg bw.
The dermal LD50 was determined to be >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute toxicity: oral

Ten male Wistar rats were exposed to test substance Decyloxirane dissolved in olive oil via oral gavage. Animals received 5000 mg/kg bw and were observed for 7 days. Diarrhea (reversible) was observed in all animals and the LD50 was determined to be >5000 mg/kg bw. In addition, a study with Tetradecyloxirane confirms the result of the read across substance.

 

Acute toxicity: dermal

In a GLP complaint OECD 402 guideline study, five Wistar rats per sex were exposed to the limit dose of 2000 mg/kg bw. The test substance Decyloxirane was administered as 2.4 mL/kg bw to the clipped epidermis and wrapped with a semi-occlusive dressing. After an exposure period of 24 hours the dressing was removed and the application site rinsed with warm water. After an observation period of 14 days animals were necropsied. No mortality occurred and no systemic clinical signs were observed. The mean body weight increased within the normal range throughout the study. Well-defined to moderate erythema, very slight or moderate edema, incrustations and scaling were observed. No macroscopic pathologic abnormalities were noted in all animals examined at the end of the study. The LD50 was determined to be >2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
There is one key study and a supproting study available.

Justification for selection of acute toxicity – dermal endpoint
There is only one study available.

Justification for classification or non-classification

Based on an oral LD50 of > 5000 mg/kg bw and a dermal LD50 of >2000 mg/kg bw, classification for acute oral toxicity and acute dermal toxicity are not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.