Registration Dossier
Registration Dossier
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EC number: 932-051-8 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP laboratory study, read-across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.
- EC Number:
- 287-494-3
- EC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.
- Cas Number:
- 85536-14-7
- IUPAC Name:
- 85536-14-7
- Details on test material:
- C10-13-sec alkyl derivative, Benzosulfonic acid (CAS #85536-14-7); purity 97.3%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Strain NMRI. Animals were approximately 22-26 g (male) and 20-25 g (female) and acclimated for 1 week to the test conditions (20 =/- 3 degrees C, 30-70% relative humidity, 12 hour light/dark cycle). Food was given daily and water was ad libitum. All animals were healthy at the time of test initiation.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- NaCl
- Duration of treatment / exposure:
- 72 hours
- Frequency of treatment:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1122 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 40 males and 40 females per dose
- Control animals:
- yes
- Positive control(s):
- Endoxan (cyclophosphamid)
Examinations
- Tissues and cell types examined:
- Cells were taken from the thigh.
- Details of tissue and slide preparation:
- Cells were mixed with cattle serum and suspended, then centrifuged. The sediment was then resuspended. The suspension was seperated in a cellulose chromatography column. This was centrifuged, and mixed with fetal calf serum and EDTA. This was air-dried for 24 hrs and stained with Giemsa.
- Evaluation criteria:
- number of polychromatid erythrocytes (PCE)
ratio of PCE to normochromatid erythrocytes (NCE)
number of cells with micronucleus
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.
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