Registration Dossier
Registration Dossier
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EC number: 205-860-2 | CAS number: 156-60-5
Skin irritation / corrosion
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:
- 1 988
- 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
- Reference substance name:
- trans-dichloroethylene
- EC Number:
- 205-860-2
- EC Name:
- trans-dichloroethylene
- Cas Number:
- 156-60-5
- Molecular formula:
- C2H2Cl2
- IUPAC Name:
- (1E)-1,2-dichloroethene
- Details on test material:
- - Purity: 99.64%
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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