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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment but available information suggests the work is probably valid. This result was obtained by valid read-across.

Data source

Reference
Reference Type:
publication
Title:
The effect of a prolonged intake of phosphoric acid and citric acid in rats
Author:
Bonting J
Year:
1956
Bibliographic source:
Voeding 17: 137

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In a non-standard repeat dose feeding study to investigate the effects of 1.2 % w/w citric acid administered in the feed on the reproductive effects in rats. The reproduction of the rats were investigated when they were 32 weeks old and had received the test compound for 29 weeks. Eleven weeks later the same animals were mated again.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): citric acid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No info
- Age at study initiation: No info
- Weight at study initiation: No info
- Fasting period before study: No info
- Housing: Non information
- Diet (e.g. ad libitum): No info
- Water (e.g. ad libitum): No info
- Acclimation period: No info

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No info
- Humidity (%):No info
- Air changes (per hr): No info
- Photoperiod (hrs dark / hrs light): No info

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on exposure:
None
Details on mating procedure:
None
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 weeks
Frequency of treatment:
Citric acid was administered in the diet (0, or 1.2% w/w).
Details on study schedule:
No data
Doses / concentrations
Remarks:
Doses / Concentrations:
Diet + 0 or 1.2 % citric acid (probably ab libitum)
Basis:
nominal in diet
No. of animals per sex per dose:
Not specified
Control animals:
yes, plain diet

Examinations

Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: No data


DETAILED CLINICAL OBSERVATIONS: No data


BODY WEIGHT: No data


FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

OTHER: Post mortem examinations

Results and discussion

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
5 other: % w/w citric acid
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: No evidence to suggest that a 5% dietary supplement of citric acid influenced either the number of young born to mice and rats or their subsequent survival up to the point of weaning.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

No indication of maternal or foetal toxicity, no teratogenicity reported.

Applicant's summary and conclusion

Conclusions:
5% w/w citric acid fed to rats did not influence either the number of young born to mice and rats or their subsequent survival up to the point of weaning.