Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 December 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP performed to sound scientific principles, with incomplete reporting and methodological deficiencies, which do not affect the quality of the presented results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: US 16 CFR 1500.3 Federal Hazardous Substances Act

Deviations:

not specified

GLP compliance:

no

Remarks:

Study predates GLP regulations.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich

EC Number:

800-172-4

Cas Number:

398141-87-2

Molecular formula:

Complex UVCB substance

IUPAC Name:

Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

The animals were housed in individual screen bottom cages and supplied with water and a commercial laboratory chow ad libitum.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test material was injected under a rubber sleeve to the clipped trunk of the animals. After 24 hours the sleeves were removed, the animals were observed over a two week period for sign of toxicity and mortality.

Duration of exposure:

The rubber sleeves were removed at 24 hours but removal of remaining test material is not noted.

Doses:

2000, 4000, and 8000 mg/kg

No. of animals per sex per dose:

3 rabbits/dose

Control animals:

no

Statistics:

No data but not applicable

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 4 000 - < 8 000 mg/kg bw

Based on:

test mat.

Mortality:

0% at 4000 mg/kg and 100% at 8000 mg/kg

Clinical signs:

No data

Body weight:

At 2000 mg/kg, body weights were lower than at the initial observation and then recovered to near initial body weights by week 2. At 4000 mg/kg, body weights increased by week 1 and remained essentially the same at week 2. Body weights were not recorded at weeks 1 and 2 for the 8000 mg/kg group because the animals died on days 5 (2 animals) and day 7 (1 animal).

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute dermal toxicity.

Executive summary:

The acute dermal toxicity of this substance was evaluated in rabbits. The test material was injected under a rubber sleeve to the clipped trunk of the animals. After 24 hours the sleeves were removed, the animals were observed over a two week period for signs of toxicity and mortality. However, only mortality and body weights were recorded. The acute dermal LD50 was determined to be between 4000 mg/kg (no deaths) and 8000 mg/kg (all animals died). In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute dermal toxicity.