Chlorotrioctylstannane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO)

Deviations:

no

GLP compliance:

no

Remarks:

Study conducted in 1973, prior to inception of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Chlorotrioctylstannane

EC Number:

219-969-8

EC Name:

Chlorotrioctylstannane

Cas Number:

2587-76-0

Molecular formula:

C24H51ClSn

IUPAC Name:

chlorotrioctylstannane

Test material form:

not specified

Specific details on test material used for the study:

- Physical form of test material: Not reported; the report implies that it is a liquid.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
- Housing: Kept separately
- Diet: ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and slightly scarified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

The test material was applied to each site (intact and slightly scarified) in quantities of 0.5 mL.

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

Six rabbits (3 males/3 females)

Details on study design:

TEST SITE
- Pre-treatment: The rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment.
- Area of exposure: 2.5 x 2.5 cm gauze pads were soaked with the test material and applied to the skin.
- Type of wrap if used: The gauze patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: The gauze patches were removed 24 hours after application.

SCORING SYSTEM
- Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

- Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising: 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: Mean of 24 and 72 hour time points

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: Mean of 24 and 72 hour time points

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Scarified skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: Mean of 24 and 72 hour time points

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: Mean of 24 and 72 hour time points

Score:

0.25

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Scarified skin

Irritant / corrosive response data:

Signs of erythema were observed on both the intact and abraded skin of 4 animals at the 24 hour observation; all reactions were scored as 1. All signs were fully reversible by the 72 hour observation. The remaining two animals exhibited no signs of erythema.

Signs of oedema were observed on both the intact and abraded skin of 2 animals at the 24 hour observation; three of the reactions were scored as 1 and the scarified skin site of one rabbit was scored as a 2. All signs were fully reversible by the 72 hour observation. The remaining four animals exhibited no signs of oedema.

Any other information on results incl. tables

Table 1: Evaluation of Skin Reactions

Animal No. and Sex		Skin Reaction	24 hours after application		72 hours after application
			Intact Skin	Scarified Skin	Intact Skin	Scarified Skin
1	M	Erythema	1	1	0	0
		Oedema	1	2	0	0
2	M	Erythema	1	1	0	0
		Oedema	1	1	0	0
3	M	Erythema	0	0	0	0
		Odema	0	0	0	0
4	F	Erythema	0	0	0	0
		Oedema	0	0	0	0
5	F	Erythema	1	1	0	0
		Oedema	0	0	0	0
6	F	Erythema	1	1	0	0
		Oedema	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the test material was determined not to be a skin irritant to rabbits.

Executive summary:

The irritation/corrosion potential of the test material was investigated following the patch-test technique described in the “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics” (1959) of the US Association of Food and Drug Officials (AFDO).

Six rabbits (3 male/3 female) of the New Zealand White strain were shaved on the whole back and flanks two days prior to treatment; the left side was slightly scarified immediately before treatment. A gauze patch soaked with the 0.5 mL of the test material was immediately applied to the prepared skin (both shaved and scarified sites). The patch was covered with a plastic film which was fixed to the body with adhesive tape. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after application.

Signs of erythema were observed on both the intact and abraded skin of 4 animals at the 24 hour observation; all reactions were scored as 1. All signs were fully reversible by the 72 hour observation. The remaining two animals exhibited no signs of erythema.

Signs of oedema were observed on both the intact and abraded skin of 2 animals at the 24 hour observation; three of the reactions were scored as 1 and the scarified skin site of one rabbit was scored as a 2. All signs were fully reversible by the 72 hour observation. The remaining four animals exhibited no signs of oedema.

Under the conditions of this study, the test material was determined not to be a skin irritant to rabbits.