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Diss Factsheets

Administrative data

Description of key information

Two acute toxicity tests were conducted, an oral and a dermal study. For both exposure routes, the acute oral median lethal dose (LD50) of the test material in rats was estimated to be greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Study conducted in compliance with agreed protocols and GLP, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

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
Quality of whole database:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles (Klimisch score 1).

Additional information

Acute oral toxicity study:

Introduction: The study was performed to assess the acute oral toxicity of the test material in the Sprague‑Dawley CD strain rat. The method was designed to meet the requirements of the OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (2001) and   Method B1bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC. At the start, one female was dosed at 300 mg/kg, then five females were dosed at 2000 mg/kg.

Mortality: There were no deaths.

Clinical Observations: Signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia, decreased respiratory rate and pilo-erection.

Bodyweight: All animals showed expected gains in bodyweight.

Necropsy: No abnormalities were noted at necropsy.

Conclusion: The acute oral median lethal dose (LD50) of the test material in the female Sprague‑Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Acute dermal toxicity:

An acute dermal toxicity study was performed according to OECD/EC test guidelines and GLP principles. Five male and five female rats were exposed to 2000 mg/kg bw for 24 hours. No mortality occurred or deviations from normal body weight gain. In the first four days after exposure, clinical signs such as lethargy, hunched posture, piloerection, chromodacryorrhoea, shallow respiration and/or ptosis were noted among all animals. General/maculate/focal erythema, scales and/or scabs were noted on the treated skin area of all animals during the observation period. For one female, hyperthermia of the treated skin area was noted on Day 3.

No macroscopic abnormalities were noted, apart from reddish discoloration of the thymus in one female. Based on these data, the LD50 acute dermal toxicity of Oxooil LS13 was considered to be greater than 2000 mg/kg bodyweight.

Justification for selection of acute toxicity – oral endpoint
One study available, performed in compliance with agreed protocols and GLP (Klimisch score 1).

Justification for selection of acute toxicity – dermal endpoint
One study available, performed according to OECD and/or EC guidelines and according to GLP principles..

Justification for classification or non-classification

Based on the available studies, the test substance is not classified for acute toxicity according to EC Regulation No. 1272/2008.