A mixture of: O,O-di(1-methylethyl)trithio-bis-thioformate; O,O-di(1-methylethyl)tetrathio-bis-thioformate; O,O-di(1-methylethyl)pentathio-bis-thioformate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study was undertaken between 6 and 13 January 1986.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Di-isopropyl xanthogen polysulphide

IUPAC Name:

Di-isopropyl xanthogen polysulphide

Details on test material:

- Name of test material (as cited in study report): D.I.X.T (Di-isopropyl xanthogentetrasulphide [polysulphide])
- Physical state: Clear yellow, oily liquid
- Storage condition of test material: ambient temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Obtained from Froxfield Rabbits, Petersfield, Hampshire.
- Age at study initiation: Approximately 10 to 13 weeks of age.
- Weight at study initiation: Weight range 2.3 to 3.0 kg, prior to treatment on Day 1
- Housing: The rabbits were individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): Free access to SDS Standard Rabbit Diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: The rabbits selected for the study were all acclimated to the laboratory environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was maintained at approximately 19°C.
- Humidity (%): Relative humidity at 30-70%.
- Air changes (per hr): Air exchange was maintained at approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
A 0.1 ml aliquot of D.I.X.T. was placed into the lower everted lid of one eye of each animal.

The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.

Duration of treatment / exposure:

Single application.

Observation period (in vivo):

Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM:
Grading and scoring of the ocular lesions were performed using the numerical scoring system (Draize) as shown in attached background material):

TOOL USED TO ASSESS SCORE:Observation of the eyes was aided by the use of a handheld torch.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

(Animal 1155)

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

(Animal 1156)

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 2 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

(Animal 1157)

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

(Animal 1158)

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

(Animal 1159)

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 2 days

Results 6

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

(Animal 1160)

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 2 days

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 1155)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 1156)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 1157)

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 1158)

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 11

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 1159)

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal 1160)

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 13

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(all animals)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

iris score

Basis:

mean

Remarks:

(all animals)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

The numerical scores awarded to the ocular reactions elicited by D.I.X.T. are given in Table 1 (see attached background material).

None of the animals gave a "positive" response.

No corneal damage or iridial inflammation was seen in any of the animals.

Mild conjunctival reactions were observed in all six animals.

The eyes were normal two to four days after instillation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Instillation of D.I.X.T. into the rabbit eye did not elicit a positive response in any of the six treated animals.

Executive summary:

Introduction.

The experimental procedure used followed the Testing Guidelines described in the Federal Register, Vol. 50, No.188, Part II of 27 September 1985 Section 798.4500 - Primary Eye Irritation.

Result.

A single application of the test item to the eye of six New Zealand White strain rabbits produced the following results:

None of the animals gave a "positive" response according to the test guideline criteria.

No corneal damage or iridial inflammation was seen in any of the animals.

Mild conjunctival reactions were observed in all six animals.

The eyes were normal two to four days after instillation.

Conclusion.

Instillation of D.I.X.T. into the rabbit eye did not elicit a positive response in any of the six treated animals according to the test guideline criteria.