Di(morpholin-4-yl) disulphide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Draize method

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Di(morpholin-4-yl) disulphide

EC Number:

203-103-0

EC Name:

Di(morpholin-4-yl) disulphide

Cas Number:

103-34-4

Molecular formula:

C8H16N2O2S2

IUPAC Name:

4-(morpholin-4-yldisulfanyl)morpholine

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or test system and environmental conditions:

no

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of DTDM, as a finely groud powder moistened with water

Duration of treatment / exposure:

24 hr

Observation period:

24, 48, 72 and 168 hours after topical application.

Number of animals:

6 animals / dose

Details on study design:

TEST SITE
- Area of exposure: to the shaved dorsal of rabbits
- % coverage: DTDM was applied to the skin under 1'' square gauze patches
- Type of wrap if used: an occlusive wrap latex rubber secured by bandaging and elastic tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hr

SCORING SYSTEM:
Dermal irritation was scored by Draize Method.

The primary irritation Index was calculated by averaging the mean scores at 24 and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: n/a

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Abraded skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.05

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Abraded skin

Irritant / corrosive response data:

Small effects were observed at 24 hours (score of 1 of each animal).
Similar effects is observed on intact skin and on abraded skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

DTDM was not irritating to the intact or abraded skin.

Executive summary:

In a pre-guideline study, 0.5 grams of 4,4'-dithiodimorpholine, as a finely ground powder moistened with water, was applied to the shaved or abraded dorsal areas of six albino rabbits. The test material was applied to the skin under 1” square gauze patches and held in contact with the skin by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape. The occlusive wrap and gauze patches were removed after 24 hours. Dermal irritation was scored by the Draize Method, and results were recorded 24, 48, 72 and 168 hours after topical application. All six rabbits showed a very slight reaction (erythema) with a score of 1 at 24 hours on both the intact or abraded skin, effects were fully reversible at 48 hours (score of 0 at 48 hours). Oedema (score 1) was recorded in one rabbit at 24 hours on the abraded skin. According to these results, 4,4'-dithiodimorpholine is considered as not skin irritant.