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Key value for chemical safety assessment

Effects on fertility

Description of key information

In the Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, conducted according to OECD Test Guideline 422 and in compliance with GLP, the reported NOAEL value for octaphenylcyclotetrasiloxane for reproductive toxicity was 1000 mg/kg bw/day (the highest dose tested). No adverse effects were observed in any of the test animals (Charles River, 2017).

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
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

The test item, octaphenylcyclotetrasiloxane formulated in propylene glycol, was administered daily by oral gavage to SPF-bred Wistar Han rats. One control group and three treated groups were tested, each consisting of 10 males and 10 females. An extra 5 animals per sex in the control and high dose group were allowed 14 days of recovery.

The animals were examined for mortality / viability, clinical signs (daily), functional observations (end of treatment), locomotor activity (end of treatment in both sexes, end of recovery in males), body weight and food consumption (at least at weekly intervals), clinical pathology (end of treatment and recovery), macroscopy at termination, organ weights and histopathology on a selection of tissues. In addition, the following reproduction/developmental parameters were determined: mating and fertility indices, precoital time, number of corpora lutea and implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development (mortality, clinical signs, body weight, anogenital distance and macroscopy). Formulations were analyzed twice during the study to assess accuracy and homogeneity.

No adverse effects were observed in any of the test animals and the reported NOAEL value for octaphenylcyclotetrasiloxane for reproductive dose toxicity was 1000 mg/kg bw/day (the highest dose tested) (Charles River, 2017).

Effects on developmental toxicity

Description of key information

In the Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, conducted according to OECD Test Guideline 422 and in compliance with GLP, the reported NOAEL value for octaphenylcyclotetrasiloxane for developmental toxicity was 1000 mg/kg bw/day (the highest dose tested). No adverse effects were observed in any of the test animals (Charles River, 2017).

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
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

The test item, octaphenylcyclotetrasiloxane formulated in propylene glycol, was administered daily by oral gavage to SPF-bred Wistar Han rats. One control group and three treated groups were tested, each consisting of 10 males and 10 females. An extra 5 animals per sex in the control and high dose group were allowed 14 days of recovery.

The animals were examined for mortality / viability, clinical signs (daily), functional observations (end of treatment), locomotor activity (end of treatment in both sexes, end of recovery in males), body weight and food consumption (at least at weekly intervals), clinical pathology (end of treatment and recovery), macroscopy at termination, organ weights and histopathology on a selection of tissues. In addition, the following reproduction/developmental parameters were determined: mating and fertility indices, precoital time, number of corpora lutea and implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development (mortality, clinical signs, body weight, anogenital distance and macroscopy). Formulations were analyzed twice during the study to assess accuracy and homogeneity.

No adverse effects were observed in any of the test animals and the reported NOAEL value for octaphenylcyclotetrasiloxane for developmental toxicity was 1000 mg/kg bw/day (the highest dose tested) (Charles River, 2017).

Justification for classification or non-classification

Based on the available data for octaphenylcyclotetrasiloxane, no classification for reproductive or developmental toxicity is required according to Regulation (EC) No 1272/2008.

Additional information