Methylsilanetriyl triacetate

Toxicity to reproduction

Administrative data

Endpoint:

fertility, other

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

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1956

Materials and methods

Principles of method if other than guideline:

Rats were fed with diets containing 1.2% citric acid (about 600 mg/kg bw/day). Exposure began 29 weeks prior to mating and continued for a few months after mating. The reproduction of the rats was investigated when they were 32 weeks old and had received the diets for 29 weeks. Eleven weeks later the same animals were mated again.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Citric acid

EC Number:

201-069-1

EC Name:

Citric acid

Cas Number:

77-92-9

Molecular formula:

C6H8O7

IUPAC Name:

citric acid

Details on test material:

- Name of test material (as cited in study report): citric acid

Test animals

Species:

rat

Strain:

not specified

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Diet (e.g. ad libitum): Basal diet: Casein 6.0 %, Dried full milk 10.0 %, Whole wheat flour 34.5 %, Potato flour 33.0 %, Peanut oil 6.5 %, Cod liver oil 0.5 %, Linseed oil 0.5 %, Brewer's yeast 5.0 %, Ca2(PO4)2 1.9 %, Na2HPO4 . 2H20 0.8 %, KCl 0.9 %, MgCO3 0.2 %, Na-citrate 0.1 %, various salts 0.1 %.

Administration / exposure

Route of administration:

oral: feed

Vehicle:

not specified

Details on exposure:

Treated rats were fed diets containing 1.2% citric acid.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Several months. Exposure began 29 weeks prior to mating and continued for a few months after mating.

Frequency of treatment:

Daily

Doses / concentrations

Dose / conc.:

1.2 other: % in diet

Remarks:

1.2 % (ca. 600 mg/kg bw/day)
Basis: nominal in diet

No. of animals per sex per dose:

No data

Control animals:

not specified

Positive control:

No data

Examinations

Parental animals: Observations and examinations:

Fertility of female rats.
The reproduction of the rats was investigated when they were 32 weeks old and had received the diets for 29 weeks. Eleven weeks later the same animals were mated again.

Statistics:

The statistical methods used in the evaluation of the results have been described in detail. The bilateral tail probability (p), i.e. the probability that the difference found be accidental, was calculated in each instance. The difference was considered significant, whenever p was smaller than 0.05.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

no effects observed

Dermal irritation (if dermal study):

not examined

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

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

not specified

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not specified

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

not specified

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Other effects:

not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:

not specified

Reproductive function: sperm measures:

not examined

Reproductive performance:

no effects observed

Description (incidence and severity):

No reproductive effects were detected.

Effect levels (P0)

1

Key result

Dose descriptor:

NOAEL

Effect level:

600 mg/kg bw/day

Based on:

test mat.

Sex:

female

Basis for effect level:

reproductive performance

Remarks on result:

other: No adverse effect observed at the highest dose tested

2

Key result

Dose descriptor:

LOAEL

Effect level:

> 600 mg/kg bw/day

Based on:

test mat.

Sex:

female

Basis for effect level:

reproductive performance

Remarks on result:

other: No adverse effect observed at the highest dose tested

Target system / organ toxicity (P0)

Key result

Critical effects observed:

no

Results: F1 generation

General toxicity (F1)

Other effects:

not examined

Developmental immunotoxicity (F1)

Developmental immunotoxicity:

not examined

Effect levels (F1)

Remarks on result:

not measured/tested

Overall reproductive toxicity

Key result

Reproductive effects observed:

no

Any other information on results incl. tables

No reproductive effects were detected. The NOAEL for reproductive effects was 600 mg/kg bw/day. The LOAEL was higher than 600 mg/kg bw/day for the same effects.

Applicant's summary and conclusion

Conclusions:

No reproductive effects were detected. The NOAEL for reproductive effects was 600 mg/kg bw/day. The LOAEL was higher than 600 mg/kg bw/day for the same effects.

Executive summary:

A fertility test was carried out with Citric Acid on rats. Animals were fed diets containing 1.2% citric acid (about 600 mg/kg bw/day). Exposure began 29 weeks prior to mating and continued for a few months after mating. The reproduction of the rats was investigated when they were 32 weeks old and had received the diets for 29 weeks. Eleven weeks later the same animals were mated again.

No reproductive effects were detected. The NOAEL for reproductive effects was 600 mg/kg bw/day. The LOAEL was higher than 600 mg/kg bw/day for the same effects.