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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Used in EU risk assessment report for zinc metal. Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration 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
Details on test material:
- Name of test material (as cited in study report): zinc monoglyerolate

Method

Species / strain
Species / strain / cell type:
lymphocytes: human
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentration in (ug/ml)
without metabolic activation 5-20
with metabolic activation 10-40
Vehicle / solvent:
none
Details on test system and experimental conditions:
No data
Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Species / strain:
lymphocytes: human
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
at 30 and 40 μg/ml
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 40 μg/ml
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data

Any other information on results incl. tables

None

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.

positive: with metabolic activation at 30 and 40 ug/ml.
Executive summary:

In an OECD 473 guideline study, zinc monoglycerolate was tested at concentrations of 5 -20 ug/ml without metabolic acitivation and 10 -40 ug/ml with metabolic activation in human lymphocytes. Zinc monoglycerolate was positive with metabolic activation at 30 and 40 ug/ml.