Carbonotrithioic acid, bis(phenylmethyl) ester

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, OECD Guideline 404

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

460-390-7

EC Name:

-

Cas Number:

26504-29-0

Molecular formula:

C15H14S3

IUPAC Name:

bis(benzylsulfanyl)methanethione

Details on test material:

- Name of test material (as cited in study report): DIBENZYL TRITHIOCARBONATE
- Physical state: yellow orange-colored solid
- Analytical purity: 96.2
- Purity test date: 2003-10-27
- Lot/batch No.: 1 UG 114
- Expiration date of the lot/batch: November 2004
- Storage condition of test material: at room temperature and protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 2.8 ± 0.1 kg.
- Housing: individually in polystyrene cages
- Diet : 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France). Ad libitum
- Water : tap water filtered by a 0.22 micron membrane. Ad libitum
- Acclimation period: at least 5 days.
- Sex : male

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70
- Air changes (per hr): 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL

Duration of treatment / exposure:

4H

Observation period:

The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
Since there were persistent irritation reactions at 72 hours, the observation period was extended up to their complete reversibility (day 11).

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: flank - Details: no data
- % coverage: no data
- Type of wrap if used: dry gauze pad, held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with moistened cotton pad.
- Time after start of exposure: 4H

SCORING SYSTEM:
Irritation evaluated for each animal according to the grading scale originally proposed by Draize and adopted by OECD test guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: yellow coloration of the skin

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: yellow coloration of the skin which could have masked a possible well-defined erythema

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: yellow coloration of the skin

Results 4

Irritation parameter:

edema score

Basis:

other: animals #1, 2 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

After a 4-hour exposure (three animals), a very slight erythema (grade 1) and a yellow coloration of the skin were observed in 1/3 animals from day 1 up to day 5. In both other animals, a yellow coloration of the skin, which could have masked a well-defined or moderate erythema (grade 2 or 3), was noted on day 1 and persisted in one of them until day 3; then a very slight or well-defined erythema (grade 1 or 2), together with a yellow coloration of the skin until day 4, was recorded up to day 5 or 9. Dryness of the skin was also observed in 1/3 animals, on day 3 only.
Due to the yellow coloration of the skin, the mean score over 24, 48 and 72 hours for erythema was not calculable for one animal; for both other animals, it was 1.0 and 1.3.
For oedema, mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008

Conclusions:

DIBENZYL TRITHIOCARBONATE is slightly irritant when applied topically to rabbits

Executive summary:

The acute dermal irritation of DIBENZYL TRITHIOCARBONATE was evaluated in rabbits according to OECD 404 guideline. The test item was applied undiluted to the skin of 3 New-Zealand White albino males rabbits and held in contact for 4 hours by means of a semi-occlusive dressing.

Due to the yellow coloration of the skin, the mean score over 24, 48 and 72 hours for erythema was not calculable for one animal; for both other animals, it was 1.0 and 1.3. For oedema, mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0.

Under the experimental conditions, DIBENZYL TRITHIOCARBONATE is slightly irritant when applied topically to rabbits.