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Toxicity to reproduction

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Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on generations indicated in Effect levels (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Not provided
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study but some basic information regarding the study is not available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Combined Repeated Dose and Reproductive / Developmental Toxicity Screening Test (Precursor Protocol of GL 422)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
Trimethoxyvinylsilane
EC Number:
220-449-8
EC Name:
Trimethoxyvinylsilane
Cas Number:
2768-02-7
IUPAC Name:
trimethoxy(vinyl)silane

Test animals

Species:
rat
Strain:
other: T23-48:Crj:CD(SD)IGS
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
Exposure period: Pre-mating period (14 days), during mating and post-mating up to 43 days for males; pre-mating (14 days) and mating period, during pregnancy and lactation, until day 4 post-partum for females
Details on mating procedure:
Not available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Premating exposure period (males): 14 days prior to mating
Premating exposure period (females): 14 days prior to mating
Duration of test: Males: 43 days; Females: day 4 of lactation
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
62.5, 250 and 1000 mg/kg bw/day in corn oil (vehicle)
Basis:
nominal conc.
No. of animals per sex per dose:
male (6/dose group) and female (12/dose group)
Control animals:
yes, concurrent vehicle
Details on study design:
Male (6/dose group) and female (12/dose group) Crj:CD(SD)IGS rats were dosed by oral gavage once a day at 0 (corn oil), 62.5, 250, and 1000 mg/kg bw/day, throughout the pre-mating period (14 days), during the mating and post-mating periods until final sacrifice for the males (at 43 days) and throughout pre-mating (14 days) and mating period, during pregnancy and lactation, until day 4 post-partum inclusive for the females (Hashima, year not available).

Post-exposure period: Yes, for a sub group of males and females for 14 days

Additional details regarding this study are provided in section 7.5.1.

Examinations

Parental animals: Observations and examinations:
Regarding reproductive toxicity, the number of estrous cases, number of conceiving days, number of pregnant females, gestation length, delivery conditions, nursing conditions, number of corpora lutea, number of implantation sites, and the implantation rate were evaluated.

Additional details regarding this study are provided in section 7.5.1.
Litter observations:
Regarding the pups, the number of births, number of stillbirths, number of pups born, and general signs were examined.
Reproductive indices:
The copulation index, fertility index, and gestation index were assessed.
Offspring viability indices:
Regarding the pups, delivery index, birth index, and live birth index were assessed.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
effects observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
effects observed, treatment-related
Reproductive function: sperm measures:
not examined
Reproductive performance:
no effects observed

Details on results (P0)

Regarding reproductive toxicity, a low number of estrous cases was noted in the 1000 mg/kg bw/day group. No changes attributable to the test article were noted for the copulation index, number of conceiving days, number of pregnant females, fertility index, gestation length, gestation index, delivery conditions, nursing conditions, number of corpora lutea, number of implantation sites, or the implantation rate.

Additional details provided in section 7.5.1

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male
Basis for effect level:
other: No effects on reproductive performance.
Dose descriptor:
NOAEL
Effect level:
250 mg/kg bw/day (nominal)
Sex:
female
Basis for effect level:
other: Low number of estrous cases.

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed

Details on results (F1)

No effects were noted for the offspring.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: No effects were noted.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAELs for reproductive performance of parental animals were estimated to be 1000 mg/kg bw/day for males and 250 mg/kg bw/day for females. The NOAEL for offspring was 1000 mg/kg bw/day.