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Toxicological information

Genetic toxicity: in vivo

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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:
1995

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

Constituent 1
Reference substance name:
87189-24-0
Cas Number:
87189-24-0
IUPAC Name:
87189-24-0
Constituent 2
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

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.