Trichlorooctylstannane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no information (year 1973)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Method: other: Procedure adopted was the patch-test technique described in the US Association of Food and Drug Officials (AFDO)'s "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics."

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trichlorooctylstannane

EC Number:

221-435-4

EC Name:

Trichlorooctylstannane

Cas Number:

3091-25-6

Molecular formula:

C8H17Cl3Sn

IUPAC Name:

trichlorooctylstannane

Details on test material:

Monooctyltin Trichloride [CAS No. 3091-25-6], TK-11386

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Six rabbits (3 males and 3 females) weighing 2 - 3 kg were shaved on the whole back and flanks 2 days before treatment with an electric clipper. Animals were kept separately in V2A wire cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved on the back and flanks and slightly scarified on the left flank

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Undiluted test material applied via gauze patch in quantities of 0.5 mL.

Duration of treatment / exposure:

Patch applied for 24 hours.

Observation period:

Test sites were observed upon patch removal and 72 hours later.

Number of animals:

6 rabbits (3 males, 3 females)

Details on study design:

The back and flanks were shaved with an electric clipper 2 days before treatment. The shaven skin on the left flank was slightly scarified immediately before treatment. A gauze patch 2.5 cm x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. TK-11386 was applied to each side in quantities of 0.5 mL.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 & 72 hours

Score:

0

Reversibility:

other: no effects seen

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

3.33

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

2.17

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Intact skin

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours after application

Score:

1.4

Remarks on result:

other: The primary irritation index is the average of all the ratings found in the 6 animals after 24 and 72 hours on intact and slightly scarified skin.

Irritant / corrosive response data:

Effects observed  included no erythema at intact and abraded skin sites at 24 and 72 hours. Slight (2/12 readings), moderate (4/12 readings), and severe edema (6/12 readings) at both intact and abraded skin sites at 24 hours.  Slight (10/12) and moderate (2/12)  edema at 72 hours on both intact and abraded skin.
The skin of the rabbits treated with the test material showed necroses  and edema; symptoms did not disappear or diminish during the 7-day observation period.

Any other information on results incl. tables

Table 1: Evaluation of Skin Reactions

Animal No.	Skin Reaction	24 hours after application		72 hours after application
		Intact skin	Scarified skin	Intact skin	Scarified skin
1 M	Erythema	0	0	0	0
	Edema	4	4	2	2
2 M	Erythema	0	0	0	0
	Edema	4	4	2	2
3 M	Erythema	0	0	0	0
	Edema	3	3	2	2
4 F	Erythema	0	0	0	0
	Edema	2	2	2	2
5 F	Erythema	0	0	0	0
	Edema	3	3	2	2
6 F	Erythema	0	0	0	0
	Edema	4	4	3	3

The table shows the irritation scores for the rabbits. The mean irritation scores for intact skin for the rabbits are as follows:

Animal 1: 3

Animal 2: 3

Animal 3: 2.5

Animal 4: 2

Animal 5: 2.5

Animal 6: 3.5

The average of these 6 scores is 2.75.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Octyltin trichloride has a primary dermal irritation index of 1.4 in rabbits which is characterised as a slight irritant to the skin of rabbits. In addition, the mean oedema score is 2.75, which classifies trichlorooctylstannane as a skin irritant according to 67/548/EEC and 1272/2008 regulations.

Executive summary:

The dermal irritation potential of octyltin trichloride was investigated in 6 New Zealand white rabbits. The test material was applied undiluted soaked in a gauze in an occlusive manner to the shaved skin of rabbits. It was also applied on the slightly scarified skin on the left flank. The patch was removed 24 hours later and the test site observed at that time as well as 72 hours after application. Skin reactions were scored on a scale of 0 - 4 for erythema and eschar formation as well as edema. An average of all 6 animals for intact and abraded skin at 24 and 72 hours was calculated (primary dermal irritation index). The test sites did not show any erythema, but showed necroses and edema. Symptoms did not disappear or diminish during the 7 -day observation period. Octyltin trichloride had a primary dermal irritation index of 1.4 in rabbits which was characterised as a slight irritant to the skin of rabbits.