Fatty acids, C16-18, zinc salts

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Used in risk assessment report for zinc sulphate, acceptable for assessment.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1974

Materials and methods

Principles of method if other than guideline:

Female Dutch rabbits were administered daily doses of 0.6, 2.8, 13 and 60 mg/kg bw by gavage during days 6-18 of gestation to evaluate the developmental toxicity of zinc sulphate.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc sulphate

EC Number:

231-793-3

EC Name:

Zinc sulphate

Cas Number:

7733-02-0

Molecular formula:

H2O4S.Zn

IUPAC Name:

zinc sulfate

Test animals

Species:

rabbit

Strain:

Dutch

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Analytical verification of doses or concentrations:

no

Details on mating procedure:

No data

Duration of treatment / exposure:

Days 6-18 of gestation

Frequency of treatment:

Daily

Duration of test:

No data

No. of animals per sex per dose:

14-19 animals/group

Control animals:

yes

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

60 mg/kg bw/day (nominal)

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

60 mg/kg bw/day (nominal)

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

- No clearly discernible effects on maternal survival, body weight gains, number of corpora lutea, implantations and resorptions were observed.

- The number of live litters, live and dead foetuses, the foetus weights and sex ratio were not affected by treatment.

- No difference in number or kind of abnormalities (in either soft or skeletal tissues) was found between exposed and control groups.

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test, administration of up to 60 mg/kg bw of unspecified zinc sulphate (ca. 24 mg or 13.6 mg Zn2+/kg bw, for anhydrate and heptahydrate, respectively) had no adverse effects on adult rabbits and their foetuses.

Executive summary:

Female Dutch rabbits (14-19 animals/group) received daily doses of 0.6, 2.8, 13 and 60 mg unspecified ZnSO4/kg bw by gavage during days 6-18 of gestation. A control group was included. All animals were observed daily for appearance and behaviour with particular attention to food consumption and body weight. Body weights were recorded on day 0, 6, 12, 18 and 29 of gestation. The urogenital tract of each animal was examined in detail. The females were sacrificed at day 29. Between 10 and 12 females were pregnant at term in all groups.

No clearly discernible effects on maternal survival, body weight gains, number of corpora lutea, implantations and resorptions were observed. The number of live litters, live and dead foetuses, the foetus weights and sex ratio were not affected by treatment. No difference in number or kind of abnormalities (in either soft or skeletal tissues) was found between exposed and control groups.

Under the conditions of the test, administration of up to 60 mg/kg bw of unspecified zinc sulphate (ca. 24 mg or 13.6 mg Zn2+/kg bw, for anhydrate and heptahydrate, respectively) had no adverse effects on adult rabbits and their foetuses.