Registration Dossier
Registration Dossier
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EC number: 231-175-3 | CAS number: 7440-66-6
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- data not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Used in EU risk assessment report for zinc metal.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Remarks:
- information on GLP not available
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 87189-24-0
- Cas Number:
- 87189-24-0
- IUPAC Name:
- 87189-24-0
- Reference substance name:
- zinc monoglycerolate
- IUPAC Name:
- zinc monoglycerolate
- Test material form:
- other: data not available
- Details on test material:
- - Name of test material (as cited in study report): zinc monoglycerolate
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- data not available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- data not available
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- continous
- Post exposure period:
- data not available
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.05 other: %
- Dose / conc.:
- 0.2 other: %
- Dose / conc.:
- 1 other: %
- No. of animals per sex per dose:
- data not available
- Control animals:
- yes
- Positive control(s):
- data not available
Examinations
- Tissues and cell types examined:
- Bone marrow cells examined for all types of chromosome and chromatid-type aberrations and hyperdiploid cells.
- Details of tissue and slide preparation:
- data not available
- Evaluation criteria:
- data not available
- Statistics:
- data not available
Results and discussion
Test results
- Sex:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- not determinable
- Additional information on results:
- - Zinc monoglycerolate was negative in this assay.
Applicant's summary and conclusion
- Conclusions:
- The information summarised in this study record was taken from the EU Risk Assessment report for zinc (EU RAR 2004) where it has been thoroughly reviewed. Due to the unavailability of the primary reference, the study was rated with reliability 4 for formal reasons. However, the results of this study will be used in the hazard assessment of the zinc category substances in a weight of evidence approach.
In a micronucleus study (Windebank et al., 1995) comparable to OECD guideline study 474, rats were fed 0.05, 0.2 and 1% zinc monoglycerolate in a purified diet. Zinc monoglycerolate was negative in this assay.
No conclusion can be drawn due to the insufficient documentation.
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