Dioctyltin dilaurate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 November 2012 to 22 November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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 dilaurate

EC Number:

222-883-3

EC Name:

Dioctyltin dilaurate

Cas Number:

3648-18-8

Molecular formula:

C40-H80-O4-Sn

IUPAC Name:

dioctyltin dilaurate

Test material form:

other: liquid (undefined)

Details on test material:

Storage: Room temperature in the dark.
State: Yellow liquid.
pH: Determined to be 6.8.

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: 2.53 - 2.59 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 12 November 2012 - 22 November 2012

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

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 initial pain reaction (see Table 2) in the first treated animal, a second animal was treated.

Observation period (in vivo):

Animals were observed up to 72 hours 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: 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:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.67

Max. score:

110

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Mean at 24, 48 and 72 hours

Results 3

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Mean at 24, 48 and 72 hours

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: Mean at 24, 48 and 72 hours

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: Mean at 24, 48 and 72 hours

Results 6

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Mean at 24, 48 and 72 hours

Results 7

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Mean at 24, 48 and 72 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Mean at 24, 48 and 72 hours

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Mean at 24, 48 and 72 hours

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 24 hour observation and persisted in one treated eye at the 48 hour observation. One treated eye appeared normal at the 48 hour observation and the other treated eye appeared normal at the 72 hour observation.

Other effects:

Both animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 3: Results

Animal	No. 1				No. 2
Time after treatment	1 h	24 h	48 h	72 h	1 h	24 h	48 h	72 h
Cornea
Degree of opacity	0	0	0	0	0	0	0	0
Area of cornea involved	0	0	0	0	0	0	0	0
Iris
Iris	0	0	0	0	0	0	0	0
Conjunctivae
Redness	2	1	1	0	2	1	0	0
Chemosis	2	1	0	0	2	1	0	0
Discharge	1	0	0	0	1	0	0	0
Individual total scores	10	4	2	0	10	4	0	0

Initial pain reaction: When the test material was instilled in the eye, the animals were observed to blink a few times within one or two minutes. The initial pain reaction of 1 was given to each animal tested.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant.

Executive summary:

The eye irritation potential of the test material was determined in accordance with standardised guidelines OECD 405 and EU Method B.5, in vivo. During the study, 0.1 mL of test material was placed into one eye of each of two rabbits and assessed for up to 72 hours to determine the grade of ocular reaction. No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 24 hour observation and persisted in one treated eye at the 48 hour observation. One treated eye appeared normal at the 48 hour observation and the other treated eye appeared normal at the 72 hour observation. Under the conditions of the test, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant.