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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12/06/1996 - 23/06/1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (OECD 404)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Purity >98%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:no data
- Age at study initiation:no data
- Weight at study initiation:2615-3446 g
- Housing:individually
- Diet (e.g. ad libitum): not precised, ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period:for a minimum of six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 +/- 3
- 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:
not required
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. At the end of four ours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionized water. 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. Skin reactions were evaluated according to the OECD scoring system and the irritant/corrosive potency of the test substance was classified according to EC Directive 83/467/EEC.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24-48-72 hours
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
Remarks:
6 rabbits
Time point:
other: 24-48-72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
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 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. 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 test material received a descriptive rating classification of moderately irritating.

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:
moderately irritating
Remarks:
Migrated information but not classified Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP).
Conclusions:
In this study, DOTE is irritant but it was not classified according to regulation EC no.1272/2008 (CLP).
Executive summary:

A GLP OECD Guideline 404 (Acute Dermal Irritation / Corrosion) test was carried out with DOT(2 -EHMA). The test substance was applied undiluted on a patch on shaved rabbit skin. The test material induced slight to moderate erythema on all rabbits and very slight edema 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.

Interpretations of result, according to the regulation EC no.1272/2008 (CLP), the test substance was moderately irritant but it was not classified under the experimental conditions.