Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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, and in compliance with GLP, no biologically significant, treatment-related effects on reproduction 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).

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
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 on reproduction 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 for parental animals and offspring (DCC, 2005).

Following daily oral administration of 100, 500, 1000 mg/kg bw/day of test substance in corn oil to 10 male and 10 female rats, no test substance-related mortality or clinical signs of toxicity occurred in parental animals or pups. There was no test substance-related effect on reproductive performance of parental animals. No macroscopic abnormalities were noted in any of the test animals or pups at necropsy. No changes were evident in any of the treated males at histopathological examinations.

Both males and females were treated with the test substance for 2 weeks prior to mating period and continued through the mating period. Males were treated for 92 days and females were treated up to and including postpartum day 3 according to treatment regime paragraph in the study report or up to gestation day 19 according to the execute summary in the study report. Offspring were observed until postpartum day 4. Necropsy was performed to all the test animals and pups at the end of the study period. A negative control group was included and gave the expected results.



Effects on developmental toxicity

Description of key information

In the key 90-day study, performed according to OECD TG 408/422 with acceptable restrictions, and in compliance with GLP, no biologically significant, treatment-related developmental toxicity was 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 for maternal and developmental toxicity was derived (DCC, 2005).

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
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 maternal or developmental toxicity was 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 for maternal and developmental toxicity was derived (DCC, 2005).

All 10 female animals were treated with the test substance for 2 weeks prior to mating period, throughout the mating period, and up to and including postpartum day 3 according to treatment regime paragraph in the study report or up to gestation day 19 according to the execute summary in the study report. Pups were observed until postpartum day 4. No abnormalities were noted in any of the test females during examination of ovaries and uterine content. No abnormalities were evident in any of the pups during external examinations. Negative control group was included and 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 reproductive or developmental toxicity according to Regulation (EC) No. 1272/2008.