Dibutoxydibutylstannane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 22 September 2010 and 23 September 2010.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

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

Principles of method if other than guideline:

An assessment of the initial pain reaction was not performed. This deviation from the General Study Plan was considered not to affect the purpose or integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dibutoxydibutylstannane

EC Number:

222-103-1

EC Name:

Dibutoxydibutylstannane

Cas Number:

3349-36-8

Molecular formula:

C16H36O2Sn

IUPAC Name:

dibutoxydibutylstannane

Details on test material:

Sponsor's identification: CAS No 3349-36-8
Purity: >95%
Description: yellow liquid
Batch number: 2009175996
Date received: 24 June 2010
Expiry date: 07 May 2011
Storage conditions: room temperature in the dark

The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.
A Certificate of Analysis was supplied by the Sponsor.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Loughborough, UK.
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.52 kg
- Housing: The animal was housed in a suspended cage.
- Diet/water (e.g. ad libitum): Free access to mains drinking water and food (2030 Teklad Global Rabbit diet supplied by Harlan Laboratories U.K. Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball.

Duration of treatment / exposure:

The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released.

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24 hours.

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n/a

SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 and 24 hours following treatment, according to the numerical evaluation given in Appendix 1, (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).

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

Remarks:

degree of opacity

Basis:

animal #1

Time point:

other: 24 hours

Score:

1

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Remarks:

area of cornea involved

Basis:

animal #1

Time point:

other: 24 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24 hours

Score:

1

Max. score:

2

Reversibility:

not reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 hours

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 hours

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Severe conjunctival irritation was noted in the treated eye one hour after treatment. Scattered or diffuse corneal opacity, iridial inflammation and severe conjunctival irritation were noted in the treated eye at the 24-Hour observation.

Other effects:

Other ocular effects noted at the 24-Hour observation were haemorrhage of the upper and lower conjunctival membranes and blood stained discharge from the conjunctival and nictitating membranes.

Any other information on results incl. tables

Due to the severity of the reactions the animal was killed for humane reasons immediately after the 24 hour observation in accordance with current UK Home Office guidelines.

Table 1              Individual Scores for Ocular Irritation

Rabbit Number and Sex	69630 Male
Time After Treatment	1 Hour	24 Hours
CORNEA
Degree of Opacity	0	1
Area of Cornea Involved	0	4
IRIS	0	1
CONJUNCTIVA
Redness	2	3HBs
Chemosis	3	3
Discharge	3	3

H = Haemorrhage of the upper and lower conjunctival membranes

Bs = Blood stained discharge from the conjunctival and nictitating membranes

Table 2              Individual Bodyweights and Bodyweight Changes

Rabbit Number and Sex	Individual Bodyweight (kg)		Bodyweight Change (kg)
	Day 0	Day 1
69630Male	2.52	2.46	-0.06

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test item was considered to be corrosive to the rabbit eye.

Executive summary:

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

- OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)

-  Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008

A single application of the test item to the non-irrigated eye of one rabbit produced scattered or diffuse corneal opacity, iridial inflammation, severe conjunctival irritation, haemorrhage of the conjunctival and nictitating membranes and blood stained discharge. Due to the severity of the reactions the animal was killed for humane reasons immediately after the 24-hour observation in accordance with current UK Home Office guidelines.

Based on the results of the study the test item was considered to be corrosive to the rabbit eye, in addition, the test item was considered to be an irritant according to EU labelling regulations Commission Directive 2001/59/EC. It is reasonable to assume that the symbol “Xi”, the indication of danger “Irritant” and the highest risk phrase R 41 “RISK OF SERIOUS DAMAGE TO EYES” are therefore required.