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Toxicological information

Repeated dose toxicity: oral

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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

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).