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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Unavailable - study report dated 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
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

Constituent 1
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:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.
Details on test material:
C10-13-sec alkyl derivative, Benzosulfonic acid (CAS #85536-14-7); purity 97.3%

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
Dose / conc.:
1 122 mg/kg bw/day (actual dose received)
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
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.

Applicant's summary and conclusion

Conclusions:
The substance was negative for genotoxicity in the in vivo mammalian erythrocyte micronucleus test.
Executive summary:

In a NMRI mouse erythrocyte micronucleus assay (equivalent to OECD guideline 474), 40 mice/sex/dose were treated via oral gavage with benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. (97.3% purity.) at doses of 0 or 1122 mg/kg bw. The vehicle was NaCl.

 

There were no signs of toxicity during the study. The test item was tested at an adequate dose. The positive control induced the appropriate response. There was not a significant increase in the frequency of micronucleated polychromatic erythrocytes. Based on the results, the test item was therefore negative for genotoxicity in the in vivo mammalian erythrocyte micronucleus test.

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