Registration Dossier
Registration Dossier
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EC number: 942-322-2 | CAS number: -
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
- Reference Type:
- secondary source
- Title:
- SIDS Category of Alkyl sulfates, Alkane sulfonates and Alpha-olefin sulfonates
- Author:
- OECD
- Year:
- 2 007
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Sulfuric acid, mono-C12-14-alkyl esters, compds. with triethanolamine
- EC Number:
- 292-216-9
- EC Name:
- Sulfuric acid, mono-C12-14-alkyl esters, compds. with triethanolamine
- Cas Number:
- 90583-18-9
- IUPAC Name:
- Sulfuric acid, mono-C12-14-alkyl esters, compds. with triethanolamine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CFW 1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to guideline.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Aqua bidest.
- Duration of treatment / exposure:
- 24 h (all doses)
48, 72 h (4000 mg/kg bw) - Frequency of treatment:
- single
- Post exposure period:
- n.a.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
400, 2000, 4000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 7
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Yes
Examinations
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES:
400 and 2000 mg/kg bw: after 24 hours
4000 mg/kg bw group: after 24, 48 and 72 hours
control groups: after 24 hours - Evaluation criteria:
- According to guideline.
- Statistics:
- Yes.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- 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
The test item was not considered to be clastogenic. - Executive summary:
No increase in micronucleated polychromatic erythrocytes was observed in this micronucleus test. Therefore, the test substance was not considered to be clastogenic.
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