Tin bis(2-ethylhexanoate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Chracterization of the material not provided

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Tin bis(2-ethylhexanoate)

EC Number:

206-108-6

EC Name:

Tin bis(2-ethylhexanoate)

Cas Number:

301-10-0

Molecular formula:

C16H30O4Sn

IUPAC Name:

tin bis(2-ethylhexanoate)

Details on test material:

- Name of test material (as cited in study report): Stannous octoate
- Physical state: liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: sanitized
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in cages with a grid floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 deg C
- Humidity (%): 52%

IN-LIFE DATES: From: 1980-04-02 To: 1980-04-09

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:

7 days

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: FDA

TOOL USED TO ASSESS SCORE: standard illumination

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24 h

Score:

12

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

48 h

Score:

13

Reversibility:

not fully reversible within: 7 days

Results 3

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

72 h

Score:

13

Reversibility:

not fully reversible within: 7 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

animal 1 - 6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: At 7 days, the response was more severe in all but one of the treated eyes, and in one eye complete corneal opacity (score 4) prevented observation of the iris.

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

animal 2 - 6

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

animal 1

Time point:

24 h

Score:

>= 0 - < 2

Max. score:

2

Remarks on result:

other: not specified

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

animal 1 - 6

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Results 8

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

animal 1 - 6

Time point:

72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

animal 1 - 6

Time point:

24/48/72 h

Score:

>= 2 - <= 3

Max. score:

3

Reversibility:

not fully reversible within: 7 d

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

animal 1 - 6

Time point:

24/48/72 h

Score:

>= 2 - <= 4

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Any other information on results incl. tables

No corneal responses were observed at 1 h, but scattered or diffuse areas of opacity (score 1) were noted in all treated eyes a t 24 h, 48 h and 72 h. At 7 days, the response was more severe in all but one of the treated eyes, and in one eye complete corneal opacity (score 4) prevented observation of the iris. Very slight iridial responses were noted in 5/6 eyes treated with stannous octoate at 1 h. The maximum score for iridial damage (2) was recorded for 5/6 treated eyes at 24 h and all observable irises a t 48 h, 72 h and 7 days. Positive responses for conjunctival redness and chemosis (2 or above) and moderate or severe discharge (score 2 or 3) were recorded in all eyes treated with stannous octoate at all readings.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Tin bis(2 -ethylhexanoate) elicited severe ocular responses involving the cornea and iris, as well as marked conjunctival responses.

Executive summary:

Six New Zealand White rabbits (3 male, 3 female) were used in the study. 0.1 mL of the test material was placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1 or 2 sec. The other eye remained untreated to serve as a control. Instillation of 0.1 ml of the test material into the eyes of rabbits resulted in corneal and iridial responses to treatment and severe conjunctival reactions which persisted throughout the test. The study was assigned a K-2 rating. Tin bis(2 -ethylhexanaote) may be classified as a severe eye irritant in view of the corneal and iridial responses to treatment and severe conjunctival reactions which persisted throughout the test.