Registration Dossier
Registration Dossier
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EC number: 231-175-3 | CAS number: 7440-66-6
Genetic toxicity: in vitro
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:
- 1 994
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
- 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
- Details on test material:
- - Name of test material (as cited in study report): zinc monoglyerolate
Constituent 1
Constituent 2
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.
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