Reaction mass of mixed xylenes and sulphur monochloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex 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 405 (Acute Eye 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

Test material form:

other: Liquid

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1ml

Observation period (in vivo):

21 days after instillation

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported


SCORING SYSTEM:
Cornea (degree of density) , Iris (reaction to light) and Conjunctivae (redness and chemosis) were observed. The scoring system is summarised below .

Results and discussion

In vitro

Results

Irritation parameter:

cornea opacity score

Value:

<= 1

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 - 72 hours

Score:

ca. 1

Max. score:

1

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24 -72 hours

Score:

ca. 0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 -72 hours

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 - 72 hours

Score:

ca. 0

Max. score:

2

Reversibility:

fully reversible within: 24 hours

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24 -72 hours

Score:

ca. 0

Max. score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24 - 72 hours

Score:

ca. 0

Max. score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 - 72 hours

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 - 72 hours

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Any other information on results incl. tables

The results are tabulated below:

Rabbit Number and Sex	Region of the Eye		One Hour	Day after Instillation
				1	2	3	4	7	14	21
3529 M	Cornea		1	1	1	1	1	1	1	1
	Iris		0	0	0	0	0	0	0	0
	Conjunctivae	Redness	1	1	0	0	0	0	0	0
		Chemosis	2	0	0	0	0	0	0	0
3530 M	Cornea		0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctivae	Redness	1	1	0	0	0	0
		Chemosis	1	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Instillation of DXDS into the rabbit eye produced mild transient conjunctival irritation in both animals. The persistent corneal opacity in one animal was not considered to be treatment related.
Based on the results of the study, classification for irritation to eyes in accordance with Regulation No. 1272/2008 is not required.

Executive summary:

A non-GLP study was performed to assess the effect of DXDS on the eye. 0.1ml of test substance was instilled into the eyes of two New Zealand White Rabbits. Observations were recorded for a maximum of 21 days after treatment. Mild transient conjunctivae irritation was observed in both animals, maximum score 2, the effects were reversible within 48 hours of instillation. One animal was noted to display mild corneal opacity with a 'scratch like' appearance, this was considered atypical and not treatment related.

The substance is considered to be mildly irritating to eyes but the requirements for classification are not met, therefore no classification with respect to eye irritancy is required.