Registration Dossier

Administrative data

Description of key information

In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, performed according to OECD TG 408/422 with acceptable restrictions, and in compliance with GLP, no biologically significant, treatment-related effects were reported in rats given 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane by oral gavage at 100, 500, 1000 mg/kg bw/day. A NOAEL of ≥1000 mg/kg bw/day was derived (DCC, 2005).

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
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

In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, performed according to OECD TG 408/422 with acceptable restrictions, and in compliance with GLP, no biologically significant, treatment-related effects were reported in rats given 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane by oral gavage at 100, 500, 1000 mg/kg bw/day. A NOAEL of >=1000 mg/kg bw/day was derived (DCC, 2005).

Following daily oral administration of 100, 500, 1000 mg/kg bw/day test substance in corn oil to 10 male and 10 female rats for 90 days, no test substance-related mortality or clinical signs of toxicity occurred during the study period. No macroscopic abnormalities in organs and tissues were noted at pathological and histopathological examinations in any of the test animals. No changes were reported at haematology and clinical chemistry examinations. Negative control group was included and treated with 0 mg/kg bw/day test substance in corn oil. On day 65 one control animal was found dead due to unknown reasons. The rest of the control animals gave the expected results.


Justification for classification or non-classification

Based on the available data for 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, no classification is required for specific target organ toxicity according to Regulation (EC) No. 1272/2008.