Tetrahydrothiophene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydrothiophene

EC Number:

203-728-9

EC Name:

Tetrahydrothiophene

Cas Number:

110-01-0

Molecular formula:

C4H8S

IUPAC Name:

tetrahydrothiophene

Details on test material:

Source: Pennwalt Corporation
Batch: 113-539-84
Purity: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton-Dutchland, Inc.3 , Denver, PA
- Age at study initiation: young adults
- Weight at study initiation: no data
- Housing: individually
- Diet (e.g. ad libitum): Lab Rabbit Chow HF (Purina #5326)
- Water (e.g. ad libitum): tap water
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-70
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

Following approximately 4 hours of exposure, the wrappings and gauze square were removed and the test site gently wiped free of excess test material with gauze and water.

Observation period:

Approximately 4.5 hours (30 minutes after removal of wrappings), 24, 48 and 72 hours (3 days after the initial administration) and 7, 10 and 14 days after treatment or until no signs of Irritation were present.

Number of animals:

6

Details on study design:

At interval all sites were evaluated for erythema and edema or other evidence of derrnal irritation according to the Draize scoring system. Adjacent areas of untreated skin were used for comparison. Special notation was made of necrosis, eschar, or other evidence of irreversible alteration of tissue structure.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24+48+72 h

Score:

2.7

Max. score:

4

Reversibility:

other: Fully reversible within 14 days, excepted for 1 animals

Remarks on result:

other: Superficial necrosis and eschar formation in 4/6 rabbits

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24+48+72 h

Score:

1.05

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

Tetrahydrothiophene produced only very slight (barely perceptible) to slight (well-defined) erythema and edema at 4.5 hours, but in four of the six animals tissue destruction (necrosis and eschar formation) became evident subsequently (between 24 hours and 7 days). Two animals showed no tissue destruction and were free of significant irritation within 2 to 10 days after test material application. Of the four animals which developed necrosis and eschar formation, three exhibited exfoliation of the eschar tissue with no significant residual irritation by Day 10 or 14 and one continued to exhibit eschar tissue at study termination (Day 14).

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Conclusions:

Tetrahydrothiophene should be considered as irritant for the skin.

Executive summary:

In a study performed according to EPA guideline #OPP 81-5 and GLP, 0.5 ml of Tetrahydrothiophene was applied for 4 hours under an occlusive dressing to the skin of 6 rabbits. Skin reactions were evalutated 30 min, 24, 48, 72 hours and 7, 10 and 14 days after the initial administration.
Tetrahydrothiophene produced only very slight (barely perceptible) to slight (well-defined) erythema and edema at 4.5 hours, but in four of the six animals tissue destruction (necrosis and eschar formation) became evident subsequently (between 24 hours and 7 days). Two animals showed no tissue destruction and were free of significant irritation within 2 to 10 days after test material application. Of the four animals which developed necrosis and eschar formation, three exhibited exfoliation of the eschar tissue with no significant residual irritation by Day 10 or 14 and one continued to exhibit eschar tissue at study termination (Day 14).
According to these results, tetrahydrothiophene should be considered as irritant for the skin.