Alkylbenzenesulphonic acid compound with alkanolamine

Genetic toxicity: in vivo

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

other: the tested substance is the acid part of the compound

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

2016

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

C10-13-sec alkyl derivative, Benzosulfonic acid (CAS #85536-14-7) as a surrogate forBenzenesulfonic acid, dodecyl- (CAS #27176-87-0) ;
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

Details on exposure:

n this study, 40 male and 40 female mice were given a single oral dose by gavage of 1122 mg/kg LAS Acid (read across) and evaluated for chromosome aberrations. Only a single dose has been evaluated which was in the range of the acute oral LD50 value for LAS Acid in rats (LD50 = 1470 mg/kg). Furthermore, slight cytotoxicity has been observed after 48 hours.

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

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:

Interpretation of results (migrated information): negative
No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.

Executive summary:

 In this study, 40 male and 40 female mice were given a single oral dose by gavage of 1122 mg/kg LAS Acid (read across) and evaluated for chromosome aberrations. Only a single dose has been evaluated which was in the range of the acute oral LD50 value for LAS Acid in rats (LD50 = 1470 mg/kg). Furthermore, slight cytotoxicity has been observed after 48 hours. No statistically significant or biologically relevant increases in the number of polychromatic erythrocytes with micronuclei were observed; therefore the test material is considered negative for cytogenicity.