Registration Dossier
Registration Dossier
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EC number: 215-693-7 | CAS number: 1344-37-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only secondary source
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Embryotoxicity of orally administered chromium in mice: Exposure during the period of organogenesis
- Author:
- Junaid M, Murthy RC and Saxena DK
- Year:
- 1 996
- Bibliographic source:
- Toxicol Lett 84:143-148
- Reference Type:
- review article or handbook
- Title:
- Toxicological profile for chromium
- Author:
- US dempartment of health and human services
- Year:
- 2 000
- Bibliographic source:
- Agency for Toxic Substances and Disease Registry, Division of Toxicology/Toxicology Information Branch
Materials and methods
Test material
- Reference substance name:
- Potassium chromate
- EC Number:
- 232-140-5
- EC Name:
- Potassium chromate
- IUPAC Name:
- Potassium chromate
- Details on test material:
- - Name of test material (as cited in study report): potassium dichromate; no additional data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Swiss albino mice
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
no detail information
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- no additional data
- Details on mating procedure:
- no additional data
- Duration of treatment / exposure:
- days 6–14 of gestation
- Frequency of treatment:
- in drinking water
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 53.2, 101.1, and 152.4 mg chromium(VI)/kg/day
Basis:
other: actually ingested eq. mg chromium(VI)
- No. of animals per sex per dose:
- 10 female animals per group
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: no data
BODY WEIGHT: Yes
- Time schedule for examinations: no data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 15
- Organs examined: no data - 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: No data
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes: No data
- Soft tissue examinations: Yes: No data
- Skeletal examinations: Yes: No data
- Head examinations: Yes: No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
No notable changes in behavior or clinical signs were observed in control or treated animals.
Reduction of gestational weight gains of 8.2 and 30% were observed for the animals in the intermediate- and high-dose groups.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
The number of dead fetuses was higher in the high-dose group and fetal weight was lower in both intermediate- and high-dose groups (high dose = 1.06 g, intermediate dose = 1.14 g) as compared to the control value of 1.3 g. The number of resorption sites were 0.31 for controls, 1.00 for the low dose, 1.70 for the intermediate dose, and 2.30 for the high dose, demonstrating a dose-response relationship.
The studies also showed that there was a significantly greater incidence of post-implantation loss in the two highest-dose groups of 21 and 34.60% as compared to control value of 4.32%.
No significant gross structural abnormalities in any of the treated dosed groups were observed except for drooping of the wrist (carpal flexure) and subdermal hemorrhagic patches on the thoracic and abdominal regions in 16% in the offspring of the high-dose group.
Significant reduced ossification in nasal frontal, parietal, interparietal, caudal, and tarsal bones were observed only in the 152.4 mg chromium(VI)/kg/day-treated animals
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
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