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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Fetus malformation observed after intraperitoneal administration of the test material to pregnant mice on different days of gestation.
GLP compliance:
no
Limit test:
no

Test material

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

Test animals

Species:
mouse
Strain:
CF-1
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Details on exposure:
No data

Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
Not applicable
Details on mating procedure:
No data
Duration of treatment / exposure:
Test 1: On Day 11 of gestation
Test 2: On Days 8-11 of gestation

Frequency of treatment:
Once
Duration of test:
No data
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
None

Examinations

Maternal examinations:
No data


Ovaries and uterine content:
No data
Fetal examinations:
- External examinations: No data
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: No data
Statistics:
No data
Indices:
No data
Historical control data:
Not data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
Test 1: No data

Test 2: Most toxic to gravid mice when dose given on Day 10 (no further details reported)

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Basis for effect level:
other: developmental toxicity
Remarks on result:
not determinable
Remarks:
no NOAEL identified
Dose descriptor:
LOAEL
Effect level:
12.5 mg/kg bw/day (nominal)
Basis for effect level:
other: developmental toxicity, overall effects, fetus malformation
Remarks on result:
other:

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects: yes

Details on embryotoxic / teratogenic effects:
Test 1: Significant incidence of skeletal defects but no soft tissue anomalies at all dose levels. Highest incidence of ripple ribs (most peculiar effect) at 25 mg/kg.

Test 2: Significant incidence of skeletal defects but no soft tissue anomalies. Most toxic to fetuses when given on Day 10. The most outstanding teratogenic response was production of ripple ribs which appeared first on Day 9 administration and become more distinct on Day 11 administration.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Conclusions:
Based on the above results, zinc chloride was found to be teratogenic in mice when administered intraperitoneally even at the lowest tested dose (12.5 mg/kg).
Executive summary:

A study was conducted to determine the teratogenic effects of zinc chloride in CF-1 albino mice. Zinc chloride was administered intraperitoneally at dose levels of 12.5, 20.5 and 25 mg/kg on Day 11 of gestation (test 1) and at 20.5 mg/kg on Days 8 -11 of gestation (test 2). In both the tests, a significant incidence of skeletal defects without soft tissue anomalies was observed at all the dose levels. In test 2, the tested dose appeared to be the most toxic to gravid mice and fetuses when given on Day 10. The most outstanding teratogenic response was production of ripple ribs in both the tests, which appeared first on Day 9 administration and become more distinct on Day 11 administration in test 2. The highest dose (25 mg/kg) produced the greatest incidence of this anomaly in test 1. Based on these results, zinc chloride was found to be teratogenic in mice when administered intraperitoneally even at the lowest tested dose (12.5 mg/kg).