Citric acid

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment but available information suggests the work is probably valid.

Data source

Reference

Reference Type:

other: summary report

Title:

Unnamed

Year:

1973

Materials and methods

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, FDA 71 54

Test animals

Species:

mouse

Strain:

other: albino CD 1

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Yes, but no details provided

Analytical verification of doses or concentrations:

not specified

Details on mating procedure:

No information reported

Duration of treatment / exposure:

Days 0 to day 10 of gestation

Frequency of treatment:

Daily
By gavage

Duration of test:

Exposure period days 6 – 10 of gestation

No. of animals per sex per dose:

30 females

Control animals:

yes, plain diet

Examinations

Maternal examinations:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked in table [No.?] were included. No, but report noted that these were done on a daily basis

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily

BODY WEIGHT: Yes
- Time schedule for examinations: On days 0, 6, 10, 14

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): no details reproted

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): no details reported
- Time schedule for examinations: YES

POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day On day 14
- Organs examined: No

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes

Fetal examinations:

- External examinations: Yes
- Soft tissue examinations: Yes: [all per litter / half per litter / #? per litter ]
- Skeletal examinations: Yes: [2/3 per litter ]
- Head examinations: Yes

Statistics:

no

Indices:

no

Historical control data:

no

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
none noted

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No indication

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

> 272 mg/kg bw/day (nominal)

Based on:

no data

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The administration of up to 272 mg/kg (body weight) of the test material to pregnant hamsters for 5 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival . The number of abnormalities seen in either soft or skeletal tissues of the test groups did, not differ from the number occurring spontaneously in the sham-treated controls.