Butylchlorodihydroxystannane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rabbits were treated with the test material under an occlusive dressing for 24 hours. Sites were scored according to Draize at 24 and 72 hours post treatment for oedema and erythema.

GLP compliance:

no

Remarks:

study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Butylhydroxyoxostannane

EC Number:

218-880-1

EC Name:

Butylhydroxyoxostannane

Cas Number:

2273-43-0

Molecular formula:

C4H10O2Sn

IUPAC Name:

butyl(oxo)stannanol

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: white powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: two test sites located lateral to the midline of the back, 10 cm apart, premoistened. The skin on one of the test sites was abraded and one was left intact.
- Type of wrap if used: Gauze patches secured with masking tape covered the site and the trunk of each animal was then wrapped with impervious plastic sheeting.
- Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit.

REMOVAL OF TEST SUBSTANCE
- At the end of 24 hours, the plastic wrappings, patches, and all residual test material were removed.

OBSERVATION TIME POINTS
- The intact and abraded test sites were examined and scored separately for erythema and oedema on a graded scale of 0 to 4. After 72 hours, the sites were again examined and scored.
- In evaluating the average irritation present, the mean scores for erythema and oedema of the intact test sites after 24 and 72 hours were added. Similarly, the mean scores for erythema and oedema of the abraded test sites after 24 and 72 hours were added. These two values were totalled and divided by four to obtain the mean primary irritation score.

SCORING SYSTEM:
- Mean Primary Irritation Score:
0 = Non-irritating
0.1 - 0.5 = Minimally Irritating
0.6 - 1.5 = Slightly Irritating
1.6 - 3.0 = Mildly Irritating
3.1 - 5.0 = Moderately Irritating
5.1 - 6.5 = Severely Irritating
6.6 - 8.0 = Extremely Irritating

- Erythema:
Barely perceptible (Edges of area not defined) = 1
Pale red in colour and area definable = 2
Definite red in colour and area well defined = 3
Beet or crimson red in colour = 4

- Oedema:
Barely perceptible (Edges of area not defined) = 1
Area definable but not raised more than 1 mm = 2
Area well defined and raised approximately 1 mm = 3
Area raised more than 1 mm = 4

- Injury in Depth:
Escharosis, Necrosis = 8
Maximum Primary Irritation Score = 8

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: abraded and intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: abraded and intact skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: abraded and intact skin

Results 6

Irritation parameter:

other: Primary irritation score

Basis:

mean

Time point:

72 h

Score:

0.3

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Reversibility:

other: 48 hour score not recorded

Remarks on result:

other: 48 hour score not recorded

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Reversibility:

other: 48 hour score not recorded

Remarks on result:

other: 48 hour score not recorded

Any other information on results incl. tables

Table 1: Summary of Results

Animal Number	Irritation Scores for Abraded Skin Sites at:				Irritation Scores for Intact Skin Sites at:
	24 hours		72 hours		24 hours		72 hours
	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
1	1	0	0	0	1	0	0	0
2	0	0	0	0	0	0	0	0
3	2	0	0	0	0	0	0	0
Mean	1.0	0.0	0.0	0.0	0.3	0.0	0.0	0.0
Subtotal	1.0				0.3

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 is not irritating to the skin.

Executive summary:

The skin irritation potential of the test material was investigated using New Zealand white rabbits.

Rabbits were treated with the test material under an occlusive dressing for 24 hours on both abraded and intact sites. Sites were scored according to Draize at 24 and 72 hours post treatment for oedema and erythema.

Under the conditions of this study the test material is not irritating to the skin.