2-ethylhexyl 12-ethyl-5,5-dioctyl-9-oxo-10-oxa-4,6-dithia-5-stannahexadecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

May 30th to October 9th 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Reliability of original study is 1

Justification for type of information:

Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

239-622-4

EC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

15571-58-1

Molecular formula:

C36H72O4S2Sn

IUPAC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products Inc, Denver, PA
- Weight at study initiation: 2828 and 4148 g.
- Housing: individual suspended mesh-bottom cages.
- Diet: purina certified rabbit chow #5322, ad libitum
- Water: municipal water, ad libitum.
- Acclimation period: minimum of six days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19-20 °C.
- Humidity: 49.0-69.9 %.
- Photoperiod: 12 hours light/12 hours dark.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml.

APPLICATION OF TEST SUBSTANCE: placed directly into the cupped lower conjunctival sac of the right eye.

Duration of treatment / exposure:

96 hours

Observation period (in vivo):

4 days.

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE: the eyes were not rinsed.

TOOL USED TO ASSESS SCORE: both eyes of the rabbits were examined for occular abnormalities prior to initiation of dosing, including the use of sodium fluorescein and UV light for detection of corneal abnormalities. Both eyes were examined macroscopically for ocular irritation using a hand-held penlight in accordance with the method of Draize.

OBSERVATIONS: animals observed twice daily for mortality. Body weight recorded on day 0 and at termination. The eyes were examined for ocular reactions in accordance with the method of Draize at approximately 1, 24, 48, and 72 hours after dosing and on day 4 if irritation persisted.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

other: all animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1M, #2M

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #3M

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #4F

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #5F, #6F

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #1M, #3M, #5F, #6F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal: #2M

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #4F

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

- None of the rabbits vocalised upon installation of the test material.
- The left (control) eyes were free of evidence of ocular irritation and other findings for the duration of the study.
- There were no test material related deaths, clinical findings, or body weight changes during the study period. The maximum average score for the substance was 8.0 at one hour post instillation. Positive conjunctival irritation was noted for 4/6 rabbits. All animals had minor conjunctival irritation. There were no iridal or corneal findings. All irritation was reversible and completely subsided by day 4.

Other effects:

One female (no. 21091) lost 390g (14 %) of initial (day 0) bodyweight. This weight loss was not considered to be related to test material administration. There were no other remarkable changes or differences observed in body weights during the study period.

Any other information on results incl. tables

Table: individual ocular irritation scores for conjuctiva

Animal/sex	1h  (R-C-D)	24h (R-C-D)	48h (R-C-D)	72h (R-C-D)	4d  (R-C-D)
1 m	2 -1 -1	1 -0 -0	1 -0 -0	0 -0 -0
2 m	2 -1 -1	1 -1 -0	1 -0 -0	0 -0 -0
3 m	1 -1 -1	1 -0 -0	0 -0 -0	0 -0 -0
4 f	2 -1 -2	2 -1 -0	1 -1 -0	1 -1 -0	0 -0 -0
5 f	1 -1 -2	0 -0 -0	0 -0 -0	0 -0 -0
6 f	2 -1 -1	0 -0 -0	0 -0 -0	0 -0 -0

R-redness; C-chemosis; D-discharge; m-male; f-female

Table: individual body weights (g)

Animal number	Sex	Initation (day 0)	Termination (interval)
21044	m	2841	2898 (day 3)
21049	m	3159	3286 (day 3)
21055	m	2876	3027 (day 3)
20638	f	4148	4120 (day 4)
21072	f	3088	3125 (day 3)
21091	f	2828	2438 (day 3)

Applicant's summary and conclusion

Interpretation of results:

other: not classified as an eye irritant according to the CLP Regulation (EC) No.1272/2008.

Conclusions:

The substance is not considered to be an eye irritant.

Executive summary:

The ocular irritation potential of the substance was evaluated according to the OECD Guideline 405 and EPA OTS 798.4500. For this reason, three male and three female New Zealand White Rabbits were used. Single doses of the test material were instilled into the lower conjuctival sac of the right eye of 6 albino rabbits. The eyelids were held closed for approximately 1 second and released. Left eyes were manipulated in a similar manner as the right eyes and served as contralateral controls. The eyes of all animals remained unwashed.

The eyes were examined for ocular reactions in accordance with the method of Draize at approximately 1, 24, 48, and 72 hours after dosing and on day 4 if irritation persisted. Sodium fluorescein was used to aid in revealing possible corneal damage at 24, 48, and 72 hours and on day 4. Positive conjunctival reactions were noted in the treated eye of 4 animals while minor conjuctival irritation was noted for all rabbits. There were no corneal or iridal findings. All irritation was reversible and completely subsided by day 4 or earlier.

Based on the irritation scores the substance is not considered to be an eye irritant.