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Registration Dossier
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Benzenesulfonic acid, para-, monoalkylation products with C14-C18 branched olefins (C15 rich) derived from propene oligomerization, calcium salt, overbased including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50
EC number: 701-205-4 | 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
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed fully in compliance with the OECD 474 Guideline and according to GLP principles. When used in assessmen to the tested subtsance, the study is considered reliable without restriction according to the criteria of Klimisch, 1997. However, since the study is used in this assessment to evaluate a similar material, the reliability is reduced to reliable with restrictions according to the criteria of Klimisch, 1997.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- calcium di(alkyl(C20-C24, even numbered)(branched)-methylbenzenesulfonate containing Distillates (petroleum), hydrotreated heavy paraffinic
- Cas Number:
- 722503-68-6
- Molecular formula:
- CaS2O6(C54-62)(H94-110)
- IUPAC Name:
- calcium di(alkyl(C20-C24, even numbered)(branched)-methylbenzenesulfonate containing Distillates (petroleum), hydrotreated heavy paraffinic
- Details on test material:
- CAS # 722503-68-6 - Benzenesulfonic acid, methyl-, mono-C20-24-branched, alkyl derivs., calcium salts
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Peanut Oil
- Details on exposure:
- See study report attached
- Duration of treatment / exposure:
- Single Treatment/exposure
- Frequency of treatment:
- Single exposure (one-treatment)
- Post exposure period:
- 2 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
6 Males / 6 Females per dose level/ of 47.0, 94.0, and 188.0 mg/kg bw; Single IP treatment; 24 harvest/48 hour timepoint
Basis:
- No. of animals per sex per dose:
- 6 males/6 females per dose level/harvest point
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (CAS 6055-19-2)
Examinations
- Tissues and cell types examined:
- Bone marrow polychromatic erythrocytes
- Details of tissue and slide preparation:
- See study report attached
- Evaluation criteria:
- See study report attached
- Statistics:
- See study report attached
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- See study report attached
Any other information on results incl. tables
See study report attached
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Not Clastogenic - Executive summary:
The objective of this study was to evaluate the test article, {CAS# 722503 -68 -6} for in vivo clastogenic activity and/or disruption of the mitotic apparatus by detecting micronuclei in polychromatic erythrocyte cells (PCEs) in Crl:CD-1(R) (ICR) BR mouse bone marrow. The test article induced signs of clinical toxicity in the treated animals but was not cytotoxic to the bone marrow (statistically significant decrease in the PCE:NCE ratio). {CAS # 722503 -68 -6} did induce a statistically increase in micronuclei in bone marrow polychronmiatic etythrocytes in the females at the high-dose level; however, the increase was not dose responsive, with within the historic control range, and was, therefore, not considered to be biologically significant. {CAS # 722503 -68 -6} is considered negative in the mouse bone marrow micronucleus test under the conditions of exposure in this assay.
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