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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
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:
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 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.