Reaction mass of mixed xylenes and sulphur monochloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed by a GLP accredited laboratory although this study was not performed to GLP. The procedures used in the study were based on EEC methodology and are sufficient to conclude on the classification and labelling of the substance.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Two male and two female rats were dosed by gavage with 2000 mg/kg bodyweight of undiluted test material.
Body weights and clinical signs were observed.
Macroscopic examinations of all animals was performed at study termination.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of mixed xylenes and sulphur monochloride

IUPAC Name:

Reaction mass of mixed xylenes and sulphur monochloride

Constituent 2

Reference substance name:

DXDS

IUPAC Name:

DXDS

Details on test material:

- Name of test material (as cited in study report): DXDS (Dixylyldisulphide)
- Physical state: Liquid
- Analytical purity: Approximately 100%
- Purity test date: 04/07/1995
- Lot/batch No.: SMD95/14
- Expiration date of the lot/batch: 6th Jan 1996
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

2 male/ 2 female animals per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: Animals weighed on day 1 and day 8 of the study.
- Necropsy of survivors performed: No
- Other examinations performed: Clinical signs and bodyweights were recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the study.

Clinical signs:

Signs of piloerection were observed in all four animals in the study, hunched posture and waddling were observed in both male animals.

Body weight:

Bodyweights were recorded on day 1 and day 8. The male animals increased body weight by 82 and 75 grams, the females increased bodyweight by 48 and 47 grams over the study period. No data is available for a control, however the report states that bodyweight gains were satisfactiory for a study of this nature.

Gross pathology:

No macroscopic abnormalities were detected in any animal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The study concludes that the acute oral LD50 for the reaction mass of mixed xylenes and sulphur monochloride is greater than 2000 mg/kg bodyweight. No classification for acute oral toxicity is required.

Executive summary:

A non-GLP study was performed to determine the effect of DXDS on the rat when dosed orally. Two male and two female rats were dosed by gavage with 2000 mg/kg bodyweight of the test substance. Clinical signs and bodyweight were recorded. Signs of piloerection were observed in all four animals, hunched posture and waddling were observed in both male animals. Bodyweight gains were considered acceptable and no macroscopic abnormalities were observed in any animal. No mortalities were observed.

Based on the results of the study, the acute oral LD50 for DXDS in the rat is greater than 2000 mg/kg bodyweight. No classification with respect to oral toxicity is required.