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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 March 1975 - 21 April 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP performed to sound scientific principles, with limited 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

Principles of method if other than guideline:

Groups of male rats (5/group) weighing between 200 and 300 g were fasted overnight and administered 0.67, 1.25, 2.5, 5.0, or 10 ml/kg by stomach tube. The animals were observed for 14 days post exposure for mortality.

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:

rat

Strain:

other: Sherman-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Groups of male rats (5/group) weighing between 200 and 300 g were fasted overnight and administered 0.67, 1.25, 2.5, 5.0, or 10 ml/kg by stomach tube. The animals were observed for 14 days post exposure for mortality.

Doses:

0.67, 1.25, 2.5, 5.0, or 10 ml/kg

No. of animals per sex per dose:

5 males/dose

Control animals:

no

Details on study design:

Groups of male rats (5/group) weighing between 200 and 300 g were fasted overnight and administered 0.67, 1.25, 2.5, 5.0, or 10 ml/kg by stomach tube. The animals were observed for 14 days post exposure for mortality.

Statistics:

N/A

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

No data

Body weight:

No data

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information not classified for acute oral toxicity on the basis of mortality data. It is not possible to assess short term STOT with available data. Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study none of the animals died up to the maximum dose tested. The LD50 was determined to be > 10 ml/kg which, using information on the density of the substance, is equivalent to > 10,267 mg/kg.

Executive summary:

The acute oral toxicity of the substance was evaluated in rats. Groups of male rats (5/group) weighing between 200 and 300 g were fasted overnight and administered 0.67, 1.25, 2.5, 5.0, or 10 ml/kg by stomach tube. The animals were observed for 14 days post exposure for mortality. No mortality was observed. The LD50 was greater than 10 ml/kg which, using information on the density of the substance, is equivalent to > 10,267 mg/kg. This substance was concluded to be not classified for acute oral toxicity in accordance with EU CLP Regulation (EC) No 1272/2008. However, clinical signs, body weight data, and gross pathology observations were not provided and so it was not possible to assess specific organ toxicity.