Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: Draize

Qualifier:

according to guideline

Guideline:

other: Standard Methods of the Food and Drug Administration

GLP compliance:

no

Remarks:

This study pre-dates the inception of GLP.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 to 3 kg

Type of coverage:

not specified

Preparation of test site:

other: abraded and non-abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 animals

Details on study design:

TEST SITE
- The backs of six rabbits were shaved 24 hours prior to the start of the experiment. A small cross-hatched abrasion was made on the right side of the animal. 0.5 mL of the test material was applied to the abraded area and an equal amount was placed on a non-abraded area.
- Type of wrap if used: the treatment area was covered with a gauze bandage and the animal restrained for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours the patches were removed and the treated areas were washed with water.

OBSERVATION TIME POINTS
- Readings were made according to the Draize method scale at 24 and 72 hours.

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

(intact skin)

Basis:

mean

Time point:

other: 24/72 h

Score:

1.6

Reversibility:

not specified

Irritant / corrosive response data:

- At 24 hours the test material caused erythema and oedema of varying degrees on both abraded and intact skin, although the reaction of abraded skin was slightly more intense. The average score at 24 hours for abraded skin was 1.5; for intact skin, 1.
- At 72 hours erythema and oedema had increased in both abraded and intact skin. Again, abraded skin had the more intense reaction. The average readings at 72 hours for abraded skin was 3.5; for intact skin, 2.3. The average score for 24 and 72 hours for abraded skin was 2.5; the average score for 24 and 72 hours for intact skin was 1.6; the combined average was 2.05, supporting data are given in Table 1.

Table 1: Results of Skin Irritation Study on the test material.

Time of reading	Animal number	Abraded skin		Intact skin
		Oedema	Erythema	Oedema	Erythema
24 hours	B36	0	1	0	0
	B37	0	1	0	1
	B38	0	1	0	1
	B39	1	1	0	1
	B40	1	1	0	1
	B41	1	1	1	1
72 hours	B36	0	1	0	0
	B37	2	2	1	2
	B38	1	3	1	2
	B39	1	3	1	3
	B40	2	2	1	1
	B41	2	2	1	1
Average scores		2.5		1.6
Combined average: 2.05

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the conditions of the study the 24 and 72 hour PII for intact skin was 1.0 and 2.3, respectively. The combined (24 hour and 72 hour) average (PII) irritation score for intact skin was 1.6.

Executive summary:

The skin irritation potential of the test material was investigated in a study broadly similar to OECD 404 using New Zealand White rabbits.

Animals were treated with 0.5 mL of test material on an abraded and non-abraded section of skin on their backs. The application was kept on the animals for 24 hours before removal and washing with water. The readings of erythema and oedema were made according to the Draize scale at 24 and 72 hours.

At 24 hours the test material caused erythema and oedema of varying degrees on both abraded and intact skin, although the reaction of abraded skin was slightly more intense. The average score at 24 hours for abraded skin was 1.5; for intact skin, 1. At 72 hours erythema and oedema had increased in both abraded and intact skin. Again, abraded skin had the more intense reaction. The average readings at 72 hours for abraded skin was 3.5; for intact skin, 2.3. The average score for 24 and 72 hours for abraded skin was 2.5; the average score for 24 and 72 hours for intact skin was 1.6.

Under the conditions of the study the 24 and 72 hour PII for intact skin was 1.0 and 2.3, respectively. The combined (24 hour and 72 hour) average (PII) irritation score for intact skin was 1.6.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

This study pre-dates the inception of GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate

EC Number:

247-666-0

EC Name:

Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate

Cas Number:

26401-97-8

Molecular formula:

C36-H72-O4-S2-Sn

IUPAC Name:

6-methylheptyl 14-methyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannapentadecan-1-oate

Test material form:

liquid

Details on test material:

- Appearance: yellowish liquid with viscosity resembling that of light corn oil

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 to 3 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

The eye was held closed for 10 seconds

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6 animals

Details on study design:

SCORING SYSTEM: Readings were made according to the Draize method at 24, 48 and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. At 48 hours ne animal had a slight redness.

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. At 48 hours ne animal had a slight redness.

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

- At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. The average irritation score at 24 hours was 2.
- At 48 hours one animal had a slight redness; no discharge or chemosis was noted at this time, The 48 hour average score was 0.3.
- At 72 hours there was no indication of irritation remaining. There was no trace of corneal damage, irial damage, or conjunctival irritation. The 72 hour score was 0.0 Supporting data are given in Table 1.

Any other information on results incl. tables

Table 1: Results of eye irritation study on the test material

Time of reading	Animal number	Cornea		Iris	Conjunctivae
		Opacity	Area		Redness	Discharge	Chemosis
24 hours	B62	0	0	0	2	1	0
	B63	0	0	0	1	0	0
	B64	0	0	0	0	0	0
	B65	0	0	0	1	0	0
	B66	0	0	0	0	0	0
	B67	0	0	0	1	0	0
24 h average score		2
48 hours	B62	0	0	0	1	0	0
	B63	0	0	0	0	0	0
	B64	0	0	0	0	0	0
	B65	0	0	0	0	0	0
	B66	0	0	0	0	0	0
	B67	0	0	0	0	0	0
48 h average score		0.33
72 hours	B62	0	0	0	0	0	0
	B63	0	0	0	0	0	0
	B64	0	0	0	0	0	0
	B65	0	0	0	0	0	0
	B66	0	0	0	0	0	0
	B67	0	0	0	0	0	0
72 h average score		0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of the study the test material was concluded not to be an eye irritant.

Executive summary:

The eye irritation potential of the test material was investigated in a study broadly similar to OECD 405 using New Zealand White rabbits.

Animals were treated with 0.1 mL of test material placed into their right eye, the eye was held closed for ten seconds and then the animal was returned to its cage. The readings were made according to the Draize scale at 24, 48 and 72 hours.

At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. The average irritation score at 24 hours was 2. At 48 hours one animal had a slight redness; no discharge or chemosis was noted at this time, The 48 hour average score was 0.3. At 72 hours there was no indication of irritation remaining. There was no trace of corneal damage, irial damage, or conjunctival irritation. The 72 hour score was 0.0.

Under the conditions of the study the test material was concluded not to be an eye irritant.