Dioctyltin oxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 November 2012 - 21 November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed to standardised guidelines OECD 405 and EU Method B.5 and in line with GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dioctyltin oxide

EC Number:

212-791-1

EC Name:

Dioctyltin oxide

Cas Number:

870-08-6

Molecular formula:

C16H34OSn

IUPAC Name:

dioctylstannanone

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Di-n-octyltin oxide
- Physical state: white solid
- Storage conditions: room 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
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.23 - 2.88 kg
- Housing: individually in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 5 November 2012 - 21 November 2012

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (equivalent to approximately 78 mg)

Duration of treatment / exposure:

- Dose administration: 0.1 mL of the test material was placed into the conjunctival sac of the right eye of one rabbit, by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were then held together for about 1 second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. After consideration of the ocular responses in the first treated animal, a second animal was treated.

Observation period (in vivo):

Animals were observed up to 7 days post administration

Number of animals or in vitro replicates:

One male initially, followed by a further male once the irritation potential was fully assessed in the first animal.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Irrigation was not performed

SCORING SYSTEM:
The reactions observed were scored in accordance with the criteria of Draize (1977).

TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 10

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

No corneal effects were noted during the study. Iridial inflammation was noted in one treated eye at the 24 hour observation. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in one treated eye at 24 hours while minimal conjunctival irritation was noted in the other treated eye at 24 hours. Minimal conjunctival irritation persisted in both treated eyes to the 48 and 72 hour observations. Both treated eyes appeared normal at the 7 day observation.

Other effects:

Both animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 2: Ocular Irritation Results

Animal	1					2
Time after treatment	1 h	24 h	48 h	72 h	7 d	1 h	24 h	48 h	72 h	7 d
Cornea
Degree of opacity	0	0	0	0	0	0	0	0	0	0
Area of cornea involved	0	0	0	0	0	0	0	0	0	0
Iris
Iris	0	1	0	0	0	0	0	0	0	0
Conjunctivae
Redness	2	2	2	1	0	2	1	1	1	0
Chemosis	2	2	1	1	0	2	1	1	1	0
Discharge	1	1	0	0	0	1	0	0	0	0

 

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

As there was no corneal involvement in any of the two treated eyes, and mean values for the 24 to 72-Hour time points were 0.2, 1.3 and 1.2 for iritis, conjunctival redness and conjunctival chemosis, respectively, the test material is not irritating in rabbit eyes. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008

Executive summary:

The eye irritation of the test material was determined in accordance with standardised guidelines OECD 405 and EU Method B.5. During the study, 0.1 mL of test material was placed into one eye of each of two rabbits and were assessed for up to 7 days to determine the grade of ocular reaction. No corneal effects were noted during the study. Iridial inflammation was noted in one treated eye at the 24 hour observation. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in one treated eye at 24 hours while minimal conjunctival irritation was noted in the other treated eye at 24 hours. Minimal conjunctival irritation persisted in both treated eyes to the 48 and 72 hour observations. All signs of irritation had completely resolved within 7 days of application.

Under the conditions of the study, the test material is not irritating in rabbit eyes. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008.