Tetrahydrothiophene 1,1-dioxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Principles of method if other than guideline:

Directive 84/449/EEC. No further information available.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydrothiophene 1,1-dioxide

EC Number:

204-783-1

EC Name:

Tetrahydrothiophene 1,1-dioxide

Cas Number:

126-33-0

Molecular formula:

C4H8O2S

IUPAC Name:

1λ⁶-thiolane-1,1-dione

Constituent 2

Reference substance name:

Sulfolane

IUPAC Name:

Sulfolane

Details on test material:

- Name of test material (as cited in study report): Sulfolane
- Physical state: Liquid, clear pale yellow
- Analytical purity: 97.4%
- Impurities: 2.6% water

Test animals

Species:

rat

Strain:

other: Crl:CD.BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K., Ltd.
- Age at study initiation: At least 7-8 weeks
- Weight at study initiation: mean Not reported
- Fasting period before study: Overnight
- Housing: 1-3 rats in stainless steel wire-mesh cages
- Diet: LAD 1, Special Diets Services, Ltd. ad libitum, except for pre-dose fast
- Water: Tap water ad libitum
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 – 23°C
- Humidity: 30 – 70%
- Air changes (per hr): Not reported
- Photoperiod: 12 hrs dark / 12hrs light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Test Site
- Type of wrap if used: a gauze dressing (approx. 6 x 8 cm) covered with waterproof adhesive tape.

Removal of Test Substance
- Washing (if done): with warm dilute detergent solution
- Time after start of exposure: 24 hours

Test Material
- Amount(s) applied (volume or weight with unit): 1.59 mL/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations made at least six times on the day of dosing and twice daily thereafter for the remainder of the study. Body weights were measured prior to dosing, and thereafter on Day 1, 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

Not needed

Results and discussion

Preliminary study:

No information is available.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths.

Clinical signs:

other: The majority of rats showed staining (yellow) of the anogenital fur and one rat showed an unkempt appearance on Day 2 only. Erythema or discoloration (yellow) of the sites of application of the test material were common after removal of the dressings on D

Gross pathology:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal rat LD50 of sulfolane was greater than 2000 mg/kg. No deaths were observed.

Executive summary:

Undiluted sulfolane at a dose of 2000 mg/kg was applied to the skin of male and female Sprague-Dawley rats for 24 hours by an occlusive patch. There were no deaths. The acute dermal LD50 of sulfolane in rats is greater than 2000 mg/kg.