Reaction mass of mixed xylenes and sulphur monochloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed by a GLP accredited laboratory although this study was not performed to GLP. The procedures used in the study were based on EEC methodology and are sufficient to conclude on the classification and labeling of the substance.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of mixed xylenes and sulphur monochloride

IUPAC Name:

Reaction mass of mixed xylenes and sulphur monochloride

Constituent 2

Reference substance name:

DXDS

IUPAC Name:

DXDS

Details on test material:

- Name of test material (as cited in study report): DXDS (Dixylyldisulphide)
- Physical state: Liquid
- Analytical purity: Approximately 100%
- Purity test date: 04/07/1995
- Lot/batch No.: SMD95/14
- Expiration date of the lot/batch: 6th Jan 1996
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

Maximum of 14 days

Number of animals:

Two females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed to removed residual test sbstance.
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72hours

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 72 hours

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72 hours

Score:

ca. 2

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 72 hours

Score:

ca. 2

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Any other information on results incl. tables

The results are presented in the table below:

Animal	E= Erythema O=Oedema	Day
		1*	2	3	4	5	6	7	8	9	10	11	12	13	14
3572	E	2^a	1^a	1^a	1^a	1^a	1^b	1^b	0^b	0^b	0	Study terminated
	O	1	1	1	0	0	0	0	0	0	0
3573	E	2^a	2^a	2^a	2	2	2^b	2^b	2^b	2^b	2^b	2^b	2^b	1^b	1
	O	2	2	2	2	2	2	2	2	1	1	2	1	1	1

* Approximately 60 minutes after removal of the dressing

^aResidual yellow staining from the test material

^bDesquamation (characterised by dryness and sloughing on the treatment site).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Mild irritancy is observed in the study however this is insufficient to trigger classification for skin irritancy, therefore no classification is required.

Executive summary:

A non-GLP study was performed to determine the effect of DXDS on intact rabbit skin. The test item was applied to the intact skin of two female rabbits using a semi-occlusive dressing for a period of 4 hours. After exposure, the dressings were removed and the test sites washed to remove residual test item. The test sites were observed for a maximum of 14 days and the observations recorded.

Well defined erythema and slight oedema accompanied by desquamation of the stratum corneum were observed in one animal,

well defined erythema and very slight oedema accompanied by desquamation of the stratum corneum were observed in the second animal. The mean scores over a 72 hour period for erythema for each animal were 1.3 and 2.0 and for oedema 1.0 and 2.0.

Mild effects were observed at the end of the 14 day observation period in one animal with the effects being reversible in the second animal. Based on the mean scores for erythema and oedema being < 2.3, no classification for skin irritancy is required.