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Administrative data

Description of key information

The key 28-day oral study, conducted according to OECD TG 407, and in compliance with GLP, reported a NOAEL value for dimethylbis(octadecyloxy)silane of 1000 mg/kg bw in rats (RCC, 1999).

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
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

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 key 28-day oral study, conducted with dimethylbis(octadecyloxy)silane according to OECD TG 407, and in compliance with GLP, reported a NOAEL value of 1000 mg/kg bw in rats (RCC, 1999).

In this study, doses of 50, 200, 1000 mg/kg bw/day of test material in corn oil were administered orally to 5 male and 5 female rats for 28 days. Observations for mortality and clinical signs of toxicity were performed daily during the study period. Detailed clinical observations were performed once a week, as well as body weights were recorded prior to commencement of treatment, then weekly and prior to scheduled death. Neurobehavioral examinations including grip strength and motor activity were performed on week 4 of the study period. Blood samples for haematological and clinical chemistry examinations were collected from all the animals during week 4 of the study. At the end of the study period all animals were sacrificed and gross pathological examinations were performed. Organs were collected and some of them were weighed and used for samples preparation for histopathological examination. Negative control group animals were also included. No deaths occurred during the 28 -day study period. No changes in expected body weight gain were observed in any of the test animals. No qualitative or quantitative differences were noted in any of the test animals when compared to the control group. No test article-related differences were noted at haematological and clinical chemistry examinations. No treatment-related changes were noted in organ weights or structure at macroscopic examinations. A number of microscopic findings were noted. The type, incidence and severity of these findings were not considered treatment-related.

Justification for classification or non-classification

Based on the available data for dimethylbis(octadecyloxy)silane, no classification for specific target organ toxicity following repeated exposure is required according to

Regulation (EC) No 1272/2008.