Registration Dossier
Registration Dossier
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EC number: 271-807-5 | CAS number: 68608-88-8 This substance is identified by SDA Substance Name: C11-C13 branched alkyl benzene sulfonic acid and SDA Reporting Number: 25-096-00.
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP laboratory study
- Justification for type of information:
- Read-across based on grouping of substances (category approach) - LAS acid.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP laboratory study
- Justification for type of information:
- Read-across based on grouping of substances (category approach) - LAS acid.
- Reason / purpose for cross-reference:
- read-across source
- 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
- 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.
- Route of administration:
- oral: gavage
- Vehicle:
- NaCl
- Duration of treatment / exposure:
- 72 hours
- Frequency of treatment:
- single dose
- 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)
- 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 - Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information): negative
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed. - Executive summary:
In a study with analogue LAS acid, no significant increases in the number of polychromatic erythrocytes with micronuclei were observed. The test substance is considered negative (not mutagenic) in the mouse micronucleus test.
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.
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:
- 85536-14-7
- Cas Number:
- 85536-14-7
- IUPAC Name:
- 85536-14-7
- 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
- Molecular formula:
- SO3C7H8-(CH2)n with n= 9-12
- IUPAC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs
- Details on test material:
- C10-13-sec alkyl derivative, Benzosulfonic acid (LAS acid) (CAS #85536-14-7); purity 97.3%
Constituent 1
Constituent 2
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
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed. - Executive summary:
In a study with analogue LAS acid, no significant increases in the number of polychromatic erythrocytes with micronuclei were observed. The test substance is considered negative (not mutagenic) in the mouse micronucleus test.
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