Registration Dossier

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
one-generation reproductive toxicity
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:
1976
Report date:
1976

Materials and methods

Principles of method if other than guideline:
This study describes an experiment designed to examine the effect of a 5% dietary supplement of citric acid on the reproductive capacity of the rats. Animals were fed a standard bran/oats dried milk diet. Control groups of female rats were compared to groups of female rats fed diets containing 5% citric acid (about 2.5 g/kg bw/day) before, during, and after mating. Six animals were in each group for the reproductive studies.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
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): Animals were fed a standard bran/oats dried milk diet.

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Animals were treated before, during, and after mating.
Frequency of treatment:
Daily
Doses / concentrations
Dose / conc.:
5 other: % in diet
Remarks:
5 % (about 2.5 g/kg bw/day)
Basis: nominal in diet
No. of animals per sex per dose:
6 female rats per group
Control animals:
yes
Positive control:
No data

Examinations

Parental animals: Observations and examinations:
Number of pregnancies in rats.
Litter observations:
Number of young born, or survival of young in rats.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Dermal irritation (if dermal study):
not examined
Mortality:
not examined
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 examined
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 examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Other effects:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
not examined
Reproductive performance:
not examined

Details on results (P0)

No effects were seen on number of pregnancies in rats.

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 2 500 mg/kg bw/day
Based on:
test mat.
Sex:
female
Basis for effect level:
other: (number of pregnancies)
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)

Clinical signs:
no effects observed
Dermal irritation (if dermal study):
not examined
Mortality / viability:
no mortality observed
Description (incidence and severity):
No effects were seen on number of young born, or survival of young in rats.
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Sexual maturation:
no effects observed
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified
Other effects:
not specified

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not examined

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not examined

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
>= 2 500 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
mortality
Remarks on result:
other: No adverse effect observed at the highest dose tested

Target system / organ toxicity (F1)

Key result
Critical effects observed:
no

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Any other information on results incl. tables

No effects were seen on number of pregnancies, number of young born, or survival of young in treated rats with ca. 2.5 g/kg bw/day, compared to controls.

Applicant's summary and conclusion

Conclusions:
No effects were seen on number of pregnancies, number of young born, or survival of young in treated rats with ca. 2.5 g/kg bw/day, compared to controls.
Executive summary:

This study describes an experiment designed to examine the effect of a 5% dietary supplement of citric acid on the reproductive capacity of the rats. Animals were fed a standard bran/oats dried milk diet. Control groups of female rats were compared to groups of female rats fed diets containing 5% citric acid (about 2.5 g/kg bw/day) before, during, and after mating. Six animals were in each group for the reproductive studies.

No effects were seen on number of pregnancies, number of young born, or survival of young in treated rats with ca. 2.5 g/kg bw/day, compared to controls.