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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
animals exposed for 24 hours
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
trans-dichloroethylene
EC Number:
205-860-2
EC Name:
trans-dichloroethylene
Cas Number:
156-60-5
Molecular formula:
C2H2Cl2
IUPAC Name:
arsenic
Details on test material:
- Purity: 99.64%

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 adult
- Weight at study initiation: rabbits weighed from 2942 to 3217 grams on the day of treatment
- Housing: housed singly in suspended, stainless steel, wire-mesh cages
- Diet: Purina Certified Rabbit Chow® #5322, ad libitum
- Water: ad libitum
- Acclimation period: approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): targeted for a temperature of 20°C ± 2°C
- Humidity (%): 50% ± 10%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL aliquot
Duration of treatment / exposure:
Approximately 24 hours
Observation period:
24, 48 and 72 hours after application of the test substance
Number of animals:
1 female and 5 male
Details on study design:
TEST SITE
- Area of exposure: approximately one square inch
- % coverage: 100%
- Type of wrap if used: A 1-inch gauze square was held in place with tape. Rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test substance in contact with the skin without undue pressure.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
> 1 - <= 3
Max. score:
4
Reversibility:
other: 4 of 6 animals had score of 2 at 72 hours
Irritation parameter:
edema score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
2
Irritant / corrosive response data:
By 24 hours following application of the test substance, no to mild erythema was observed in the treated rabbits. At 48 hours, no to moderate erythema was observed. No or mild erythema was observed at 72 hours. No edema was observed throughout the study.

Any other information on results incl. tables

Table 1: Individual Animal Dermal Effects

ERYTHEMA

Rabbit Number

Evaluation after Removal of Test Substance

24 Hours

48 Hours

72 Hours

22334

0

2

2

22337

0

0

2

22338

2

0

0

22340

0

0

0

22341

1

2

2

22368

2

3

2

 

EDEMA

Rabbit Number

Evaluation after Removal of Test Substance

24 Hours

48 Hours

72 Hours

22334

0

0

0

22337

0

0

0

22338

0

0

0

22340

0

0

0

22341

0

0

0

22368

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Under the conditions of this study, the test substance is not a skin irritant.
Executive summary:

The test substance was evaluated for acute skin irritation potential in 1 female and 5 male rabbits. A 0.5 mL aliquot was applied to the clipped test site then covered with gauze and rubber sheeting. After 24 hours the test site was washed then scored according to the Draize scale. Erythema was observed in 5 of the 6 animals. Draize scores ranged from 0 to 2.3 across 24, 48, and 72 hours. No edema was observed throughout the study.