2-ethylhexyl 12-ethyl-5,5-dioctyl-9-oxo-10-oxa-4,6-dithia-5-stannahexadecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

June 12th to 23rd, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Reliability of original study is 1

Justification for type of information:

Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

239-622-4

EC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

15571-58-1

Molecular formula:

C36H72O4S2Sn

IUPAC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2615-3446 g.
- Housing: individually.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: for a minimum of six days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C.
- Humidity: 30-70 %.
- Photoperiod: 12-h light/dark period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml.

Duration of treatment / exposure:

4 hours

Observation period:

12 days

Number of animals:

Four males and two females

Details on study design:

TEST SITE
- On the day to dosing, the hair was removed from the backs and flanks of the rabbits using an Oster small animal clipper.
- Area of exposure: approximately 6.5 cm^2.
- Type of wrap if used: a secured two-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform tape was used. Plaxtic restraint collars were applied and remained on the animals for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE: at the end of four hours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionized water.

OBSERVATION TIME POINTS: the application sites were observed for erythema, edema and other dermal findings approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and once daily through day 11 if irritation persisted.

SCORING SYSTEM: skin reactions were evaluated according to the OECD scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: # 20850

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: #20899

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 3

Irritation parameter:

erythema score

Basis:

animal: #20856, #20873, #20877, #20914

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 4

Irritation parameter:

edema score

Basis:

animal: #20850

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal: #20856, #20877

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal: # 20873, # 20899, #20914

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

Six and four rabbits had slight to moderate erythema and very slight edema, respectively. Desquamation was noted for three animals. Edema completely subsided by day 6 or earlier. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier.

Any other information on results incl. tables

Primary dermal irritation study in albino rabbits Individual dermal scores
0.5 ml/site
			Erythema					Edema
Animal	Sex	Site	0.5-1h	24h	48h	72h	Site	0.5-1h	24h	48h	72h
20850	M	A	2	3	3	3	A	0	1	1	1
20856	M	A	1	2	2	2	A	0	0	0	0
20873	M	A	0	2	2	2	A	0	0	0	1
20877	M	A	1	2	2	2	A	0	0	0	0
20899	F	A	1	1	2	2	A	0	0	0	1
20914	F	A	2	2	2	2	A	0	0	0	1
		Total	7	12	13	13	Total	0	1	1	4
h = hours; M = Male; F = Female

Applicant's summary and conclusion

Interpretation of results:

other: not classified as a skin irritant according to the CLP Regulation (EC) No.1272/2008

Conclusions:

The substance is not considered to be a skin irritant.

Executive summary:

The skin irritation potential of the test material to rabbits was evaluated according to the OECD Guideline 404. For this reason, four male and two female New Zealand white rabbits were treated with the test material (undiluted) on a semi-occlusive patch. After 4 hours of exposure the patch was removed, the treated sites were wiped with disposable paper towels moistened with deionized water and the skin reactions was observed at 30 -60 min, 24, 48, and 72 hours post-removal and once daily through day 11 if irritation persisted. The skin reactions were scored according to the OECD scoring system.

Desquamation was noted for three animals. Edema completely subsided by day 6 or earlier. All irritation was reversible and completely subsided by day 11 or earlier. The erythema score (mean: 24/48/72 hr) was 3 for one animal, 2 for 4 animals and 1.66 for one animal. The edema score (mean 24/48/72 hr) was 1 for one animal, 0 for two animals and 0.33 for three animals.

The substance is not considered to be a skin irritant.