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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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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:
1998
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

Constituent 1
Chemical structure
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

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.