2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

The control eye of animal #G8794/F was not scored at one hour. This did not appear to impact the study results since all scores for the animal were zero for the remainder of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

260-828-5

EC Name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

57583-34-3

Molecular formula:

C31H60O6S3Sn

IUPAC Name:

2-ethylhexyl 10-ethyl-4-({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate

Test material form:

liquid

Details on test material:

- Analytical purity: 94.8 %
- Composition of test material, percentage of components: monomethyltin (ethylhexylthioglycolate) 94.8 %; dimethyltin (ethylhexylthioglycolate) 2.1 %
- Purity test date: June 30, 2006
- Lot/batch No.: 51VOC389
- Expiration date of the lot/batch: June 30, 2009
- Storage condition of test material: dry, cool, ventilated area

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: 3 months old
- Weight at study initiation: 2.3 to 2.5 kg
- Housing: housed 1/cage in suspended cages
- Diet (e.g. ad libitum): PMI Rabbit Chow provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14-21 °C
- Humidity (%): 72- 92 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle


IN-LIFE DATES: From: June 26, 2006 To: June 29, 2006

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral eye of dosed rabbit

Amount / concentration applied:

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

VEHICLE no vehicle used

Duration of treatment / exposure:

24 hour

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated and control eye were washed with saline following the 24 hour observation interval for approximately one minute using a volume and velocity of flow which did not cause injury.
- Time after start of exposure: 24 hours


SCORING SYSTEM: graded according to the numerical Draize technique


TOOL USED TO ASSESS SCORE: Mini-Maglite(R) flashlight equipped with a high intensity bulb

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hour

Score:

0

Max. score:

80

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hour

Score:

0

Max. score:

10

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hour

Score:

0.11

Max. score:

20

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hour

Score:

0

Irritant / corrosive response data:

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared by 48 hours.
All three control eyes appeared normal at each observation period.

Other effects:

There were no abnormal physical signs noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Ocular administration of the test substance produced conjunctival irritation which cleared by 48 hours.

Executive summary:

To determine the irritant and/or corrosive effects, the test substance was instilled into the rabbit eye. This study was designed to follow OECD Guideline 405.

Three healthy New Zealand White rabbits (2 males - 1 female), free from evidence of ocular irritation and corneal abnormalities, were dosed with the test substance. The test article (0.1 mL) was placed into the conjunctival sac of one eye of each rabbit. The contralateral eye served as control. The treated and untreated eye of each rabbit were examined and scored by the Draize technique at 1, 24, 48 and 72 hours postdose. Both eyes were washed with saline following the 24 hour observation interval for approximately one minute using a volume and velocity of flow which did not cause injury. The eye irritation score for each rabbit was calculated each day. Body weights were recorded pretest and at termination.

Treated Eyes: There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared by 48 hours.

Control Eyes: All three control eyes appeared normal at each observation period.

There were no abnormal physical signs noted during the observation period.

Ocular administration of the test substance produced conjunctival irritation which cleared by 48 hours.