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

Endpoint summary

Description of key information

ORAL
LD50 >10 mL/kg (> 10,267 mg/kg); study performed in line with US 16 CFR 1500.3 Federal Hazardous Substances Act; Gabriel (1975)
DERMAL
LD50 >4000 <8000 mg/kg bw; study performed in line with US 16 CFR 1500.3 Federal Hazardous Substances Act; Harris (1975)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

No data

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

One reliable study available, therefore quality of whole database is sufficient.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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

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.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

One reliable study available, therefore quality of whole database is sufficient.

Additional information

Oral

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.

Inhalation

Integrated testing strategies for acute toxicity state that the determination of the most likely route of exposure needs to take into account not only the substance is manufactured and handled but also the physicochemical properties of the substance. Testing for acute toxicity via the inhalation route is waived.

Dermal

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 sign 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.

Justification for selection of acute toxicity – oral endpoint
The available study is reliable and can support the development of a chemical safety assessment.

Justification for selection of acute toxicity – dermal endpoint
The available study is reliable and can support the development of a chemical safety assessment.

Justification for classification or non-classification

The substance does not require classification in accordance with the criteria specified in EU CLP (Regulation (EC) No. 1272/2008).