Toluene-4-sulphonic acid

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: gene mutation

Remarks:

Type of genotoxicity: bone marrow chromosome aberration

Type of information:

other: Read across from a member of the Hydrotropes category

Adequacy of study:

supporting study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.5385 (In Vivo Mammalian Cytogenetic Tests: Bone Marrow Chromosomal Analysis)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

yes (incl. QA statement)

Type of assay:

mammalian bone marrow chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Calcium xylenesulphonate

EC Number:

248-829-9

EC Name:

Calcium xylenesulphonate

IUPAC Name:

calcium xylenesulphonate

Results and discussion

Test results

Test results 1

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Pilot study
Mortality occurred within two hours of dose administration in 5/5 males and 5/5 females at 5000 mg/kg and within one day of dose administration in 2/2 males at 1000 mg/kg. Clinical signs, which were noted on the day of dosing with 1000 mg/kg, included lethargy. All other surviving animals appeared normal throughout the observation period.

Toxicity study
Mortality occurred within two days of dose administration as follows: 5/5 males and 5/5 females at 1000 mg/kg and 3/5 males and 0/5 females at 700 mg/kg. Clinical signs included: lethargy in male and female mice at 500, 700, and 1000 mg/kg. One male mouse treated with 200 mg/kg also exhibited lethargy. In the male mouse group treated with 700 mg/kg, one mouse exhibited piloerection and another mouse, that eventually died, was prostrate with irregular breathing. All other animals appeared normal throughout the observation period. The LD50/3 was calculated by probit analysis to be approximately 723 mg/kg. The high dose for the micronucleus test was set at 580 mg/kg which was estimated to be approximately 80% of the LD5O/3.

Micronucleous test
No mortality was observed in any male or female mice in the micronucleus study. Clinical signs following dose administration included lethargy in male and female mice at 580 mg/kg

A 36% reduction in the ratio of polychromatic erythrocytes to total erythrocytes was observed in male mice sacrificed at 72 hours with 580 mg/kg relative to their respective vehicle controls. The presence of lethargy and reduction in the frequency of polychromatic erythrocytes in the bone marrow demonstrate that suitable dose levels were used. No significant increases in micronucleated polychromatic erythrocytes were observed in either sex at any time period relative to their respective vehicle controls. The positive control induced a significant increase in micronucleated polychromatic erythrocytes in both sexes. The vehicle (negative) and positive controls fulfilled the requirements for determination of a valid test.

Any other information on results incl. tables

See attached tables.

Applicant's summary and conclusion

Conclusions:

Not genotoxic

Executive summary:

The potential of Sodium p-cumenesulphonate to cause cytogenetic damage which results in the formation of micronuclei containing lagging chromosome fragments or whole chromosomes was assessed following official guideline OECD 474, Mammalian Erythrocyte Micronucleus Test. No significant increases in micronucleated polychromatic erythrocytes were observed in male or female ICR mice at 24, 48 or 72 hours after dose administration relative to their respective vehicle controls. The results of the assay indicate that under the conditions described in this report, Calcium xylene sulphonate did not induce a significant increase in micronucleated polychromatic erythrocytes in either male or female ICR mice.