Registration Dossier
Registration Dossier
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EC number: 240-178-9 | CAS number: 16039-53-5
Developmental toxicity / teratogenicity
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:
- 1 976
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 substance name:
- Zinc chloride
- EC Number:
- 231-592-0
- EC Name:
- Zinc chloride
- Cas Number:
- 7646-85-7
- IUPAC Name:
- zinc dichloride
- Details on test material:
- - Name of test material (as cited in study report): Zinc chloride
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Details on test animals or test system 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).
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