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

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

in vivo study in the rabbit. The existing in vivo data is considered to fulfil the in vitro eye irritation requirement.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

, control eyes were not scored at 1 hour.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

260-829-0

EC Name:

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

Cas Number:

57583-35-4

Molecular formula:

C22H44O4S2Sn

IUPAC Name:

2-ethylhexyl 2-{[({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)dimethylstannyl]sulfanyl}acetate

Details on test material:

- Physical state: liquid
- Analytical purity: 62.8%
- Purity test date: 2006-06-30
- Lot/batch No.: 2083498
- Expiration date of the lot/batch: 2008-11-01
- Stability under test conditions: stable
- Storage condition of test material: room temperature and humidity

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: Approximately 4 months old
- Weight at study initiation: 2.2 – 2.6 kg
- Housing: The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three times /week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21◦C
- Humidity (%): 64-86 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle


IN-LIFE DATES: From: 2006-07-03 To: 2006-07-06

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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



VEHICLE- none

Duration of treatment / exposure:

24 hours

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 eyes of each rabbit were washed with saline following 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: Draize

TOOL USED TO ASSESS SCORE:
Observations were performed using a Mini-Maglite® 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: 24-72 hour

Score:

0

Max. score:

80

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

10

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

12

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Conjunctival irritation, noted in 3/3 eyes at 1 hour, cleared by 24 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

8

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Conjunctival irritation, noted in 3/3 eyes at 1 hour, cleared by 24 hours

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 24 hours.

Other effects:

There were no abnormal physical signs noted during the observation period

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria.

Conclusions:

Ocular administration produced conjunctival irritation which cleared by 24 hours.

Executive summary:

To determine the irritant and/or corrosive effects, if any, of the test substance when instilled into the rabbit eye. Three healthy New Zealand White rabbits (2 males; 1 female) free from evidence of ocular irritation and corneal abnormalities, were dosed with 0.1 mL placed into the conjunctival sac of one eye of each rabbit. The contralateral eye served as control. The treated eye of each rabbit was examined and scored by the Draize technique at 1, 24, 48 and 72 hours postdose and the untreated eye was scored at 24, 48 and 72 hours. 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.

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared by 24 hours. All three control eyes appeared normal at each observation period. There were no abnormal physical signs noted during the observation period.