Registration Dossier
Registration Dossier
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EC number: 221-209-5 | CAS number: 3031-66-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Hex-3-yne-2,5-diol
- EC Number:
- 221-209-5
- EC Name:
- Hex-3-yne-2,5-diol
- Cas Number:
- 3031-66-1
- Molecular formula:
- C6H10O2
- IUPAC Name:
- hex-3-yne-2,5-diol
- Test material form:
- other: liquid
- Details on test material:
- Liquid, yellowish, clear
Purity: 94.9%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- About 5-8 weeks old; supplied by Charles River Laboratories Germany GmbH
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- deionized water
- Frequency of treatment:
- once
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
25 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
50 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 20 mg/kg bw cyclophosphamide; 0.15 mg/kg bw vincristine sulfate
Examinations
- Evaluation criteria:
- 2 000 polychromatic erythrocytes (PCE) were evaluated for the occurrence of micronuclei from each animal of every test group, so in total 10 000 PCEs were scored per test group. The normochromatic erythrocytes (= normocytes I NCE) which occur were also scored.
- Statistics:
- The statistical evaluation of the data was carried out using the program system MUKERN (BASF SE).
The asymptotic U test according to MANN-WHITNEY (modified rank test according to WILCOXON) was carried out to clarify the question whether there are statistically significant differences between the vehicle control group and the treated dose groups with regard to the micronucleus rate in polychromatic erythrocytes. The relative frequencies of cells containing micronuclei of each animal will be used as a criterion for the rank determination for the U test. Statistical significances were identified as follows:
* p <= 0.05
** p <= 0.01
However, both biological relevance and statistical significance should be considered
together.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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