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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1973

Materials and methods

Principles of method if other than guideline:
Female hamsters were administered daily doses of 0.9, 4.1, 19 and 88 mg/kg bw by gavage during days 6-10 of gestation to evaluate the developmental toxicity of zinc sulphate.
GLP compliance:
not specified
Limit test:
no

Test material

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

Test animals

Species:
hamster
Strain:
not specified

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 6-10 of gestation
Frequency of treatment:
Daily
Duration of test:
No data
Doses / concentrations
Remarks:
Doses / Concentrations:
0.9, 4.1, 19 and 88 mg/kg bw
Basis:
other: nominal
No. of animals per sex per dose:
23-25 animals/group
Control animals:
yes

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
88 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:
88 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 88 mg/kg bw of unspecified zinc sulphate (ca. 35.2 mg or 19.9 mg Zn2+/kg bw, for anhydrate and heptahydrate, respectively) had no adverse effects on adult hamsters and their foetuses.
Executive summary:

Female hamsters (23-25 animals/group; outbred strain of golden hamster) received daily doses of 0.9, 4.1, 19 and 88 mg unspecified ZnSO4/kg bw by gavage during days 6-10 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, 8, 10 and 14 of gestation. The females were sacrificed at day 14. The urogenital tract of each animal was examined in detail. Between 21 and 24 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 88 mg/kg bw of unspecified zinc sulphate (ca. 35.2 mg or 19.9 mg Zn2+/kg bw, for anhydrate and heptahydrate, respectively) had no adverse effects on adult hamsters and their foetuses.