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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 June 1996 to 23 June 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
other: read-across target
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1), see attached justification.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: Mean individual scores : 3-2-2-2-1.67-2
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Mean individual scores : 1-0-0.33-0-0.33-0.33

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
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

Constituent 1
Reference substance name:
Dioctyltin bis (2-EHMA), purity >98%
IUPAC Name:
Dioctyltin bis (2-EHMA), purity >98%
Constituent 2
Chemical structure
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:
8-Oxa-3,5-dithia-4-stannatetradecanoic acid, 10-ethyl-4,4-dioctyl-7-oxo-, 2-ethylhexyl ester
Details on test material:
Purity >98%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- 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 (°C): 20 ± 3°c
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12-h light/dark period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted, 0.5 mL on a 6.5 cm² area (1 x 1 inch).
Duration of treatment / exposure:
4 hours
Observation period:
12 days
Number of animals:
Four males and two females
Details on study design:
On the day to dosing, the hair was removed from the backs and flanks of the rabbits using an Oster small animal clipper. Each 0.5 mL dose was applied to an area of skin approximately 6.5 cm² under a secured two-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform tape. Plaxtic restraint collars were applied and remained on the animals for the duration of the exposure period. Each animal received a single, four-hour, semi-occluded exposure to the test material. At the end of four hours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionised water. The application sites were observed for erythema, oedema 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. Skin reactions were evaluated according to the OECD scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: Mean individual scores : 3-2-2-2-1.67-2
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Mean individual scores : 1-0-0.33-0-0.33-0.33
Irritant / corrosive response data:
Six and four rabbits had slight to moderate erythema and very slight oedema, respectively. Desquamation was noted for three animals. Oedema 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. Desquamation was noted for three animals.

Any other information on results incl. tables

Primary dermal irritation study in albino rabbits

Individual dermal scores

0.5 mL/site

 

 

 

Erythema

 

Oedema

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 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 in a study which was conducted in accordance with the stamdardised guideline OECD 404, under GLP conditions.

During the study, they test material was applied undiluted on a patch on shaved rabbit skin. The exposure period was 4 hours.

The test material induced slight to moderate erythema on all rabbits and very slight oedema on four animals. Three rabbits had desquamation. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier.

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