Diacetoxydi-tert-butoxysilane

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

No specific test guideline was reported; however, a scientifically defensible approach was used to conduct the study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1971

Report date:

1970

Materials and methods

Principles of method if other than guideline:

Male rats of the Wistar strain were used. They came from mothers who were transferred from a stock ration to a vitamin B12-deficient ration at parturition and continued on the deficient ration during lactation. After being weaned at 25 days of age, they were divided at about 28 days of age into experimental groups. Since variation in growth response on the vitamin B12- deficient ration occurred between litters due to such factors as the amount of stored vitamin derived from the mother, one member of each litter was assigned randomly to each group and then started on the experimental rations. Weight gain averages are based on groups of littermates in which both members of the litter survived the experimental period. They were fed ad libitum a 25% protein, vitamin B12-deficient ration either as such or modified by the addition of fatty acids (sodium acetate) for four weeks. The body weights were determined.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium acetate

EC Number:

204-823-8

EC Name:

Sodium acetate

Cas Number:

127-09-3

IUPAC Name:

sodium acetate

Details on test material:

- Name of test material (as cited in study report): sodium acetate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

oral: feed

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Four weeks

Frequency of treatment:

Daily

Doses / concentrations

Dose / conc.:

3.58 other: % (nominal in diet)

Remarks:

(approximately 3600 mg/kg bw/day)

No. of animals per sex per dose:

13 male rats per dose

Control animals:

no

Examinations

Observations and examinations performed and frequency:

Body weights

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Neuropathological findings:

not examined

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not examined

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

>= 3 600 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male

Basis for effect level:

other: Based on no effects observed at the only dose tested

Target system / organ toxicity

Key result

Critical effects observed:

no

Any other information on results incl. tables

No effects on growth or survival were observed at ca. 3600 mg/kg bw/day (the only dose tested).

Applicant's summary and conclusion

Conclusions:

No effects on growth or survival were observed at ca. 3600 mg/kg bw/day (the only dose tested, during 28 days).

Executive summary:

Male rats of the Wistar strain were used. They came from mothers who were transferred from a stock ration to a vitamin B12-deficient ration at parturition and continued on the deficient ration during lactation. After being weaned at 25 days of age, they were divided at about 28 days of age into experimental groups. Since variation in growth response on the vitamin B12- deficient ration occurred between litters due to such factors as the amount of stored vitamin derived from the mother, one member of each litter was assigned randomly to each group and then started on the experimental rations. Weight gain averages are based on groups of littermates in which both members of the litter survived the experimental period. They were fed ad libitum a 25% protein, vitamin B12-deficient ration either as such or modified by the addition of fatty acids (sodium acetate) for four weeks. The body weights were determined. No effects on growth or survival were observed at ca. 3600 mg/kg bw/day (the only dose tested).