Tricalcium dicitrate

Toxicity to reproduction

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

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:

2-hydroxypropane-1,2,3-tricarboxylic acid

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 or test system 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.