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Description of key information

The test substance was found to cause no mortality upon acute oral and dermal exposure to rats of 5000 and 2000 mg/kg bw, respectively. Similarly, no mortality was observed in rats in the acute oral toxicity study with 5000 mg/kg bw of the C12-analogue. No findings were noted regarding body weight development or gross pathology. Transient mild clinical signs resolved within the observation period. All three studies are adequately reported and in their design equivalent or similar to the respective OECD testing guidelines.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
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:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral Toxicity

In the key study each five male and female Sprague-Dawley rats were given a single gavage dose of 5000 mg/kg bw in 50% polyethylene glycol. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. This study contains less detail on experimental performance than the second study with a structural analogue but is otherwise considered adequate for hazard assessment.

The findings of the key study are consistent with the results of a second acute oral toxicity study performed with a structural analogue. This study was performed and reported similar to the requirements of OECD testing guideline 423. It was performed prior to the introduction of GLP. The test item is an analogue substance that differs in having two C12 alkyl chains instead of two C18 alkyl chains. The shorter alkyl chain is expected to result in slightly more favourable solubility and absorption after uptake. Considering the 1.3 fold difference in molecular weight, application of the C12 analogue results in a higher number of molecules so that overall, any hazard identified for the analogue is considered relevant for the target substance. The read-across study was performed in five male and five female Tif:RAIf(SPF) rats with a limit dose of 5000 mg/kg bw that was applied by gavage using CMPS80 as vehicle. No mortality occurred. Dyspnea was observed between day 1 and day 10; ruffled fur between day 1 and day 9; body position-curved between day 1 and 6. The animals recovered within 11 days.

Dermal Toxicity

The key study for acute dermal toxicity was performed with a well-characterized test material according to GLP and a protocol similar to OECD Guideline 402. In this study the substance was applied as a paste in arachis oil to the skin of 5 male and 5 female rats (Tif: RAIf (SPF) at a dose of 2000 mg/kg bw and covered with a semi-occlusive dressing for 24 hours. There were no deaths during the 14-day observation period. Piloerection, hunched posture, and dyspnea were seen. The animals recovered within 2 to 3 days. No deviations from normal morphology were found upon necropsy. The LD50was higher than 2000 mg/kg bw.

InhalationToxicity

No experimental data is available regarding acute inhalation toxicity.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.