Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine

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:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP laboratory 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

Test material information

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

Molecular formula:

None available - not a single isomer - see remarks

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

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:

The substance was negative for genotoxicity in the in vivo mammalian erythrocyte micronucleus test.

Executive summary:

There was no significant increases in the number of polychromatic erythrocytes with micronuclei.The substance was negative for genotoxicity in the in vivo mammalian erythrocyte micronucleus test.