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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
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 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
dosed with 5000 mg/kg bodyweight
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3115 to 3312 grams
- 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): 20°C ± 2°C
- Humidity (%): 50% ± 10%.
- Photoperiod: 12-hour light/12-hour dark cycle

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 190 square centimeters
- Type of wrap if used: After application of the test material, sterile gauze pads were applied to the treated site. The rabbits were then wrapped with successive layers of plastic film, stretch gauze bandage and elastic adhesive bandage.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
Male - 2
Female - 3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for clinical signs were made approximately 24 hours after dosing and then daily thereafter for 14 days (excluding weekends). Observations for mortalities were made daily throughout the study.
- Frequency of weighing: weighed on days 1, 7 and 14 following treatment
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
None
Clinical signs:
The test item produced mild or moderate erythema and no to mild oedema in the treated rabbits by approximately 24 hours. The dermal irritation in the rabbits became more severe during the study. At day 7, mild to severe erythema with slight to severe oedema, necrosis, fissuring of the skin and raw areas was observed. At day 8, the dermal irritation in 1 rabbit began to resolve. However, at study termination (day 14), mild to severe erythema with no to severe oedema, necrosis, fissuring of the skin, raw areas and epidermal scaling was still evident in the treated rabbits.
Body weight:
Body weight losses of up to 3% of initial body weight were observed in 3 rabbits at 1 day following treatment.

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).
LD50 > 5000 mg/kg
Executive summary:

A single dose of the test item was applied to the clipped, intact skin of 2 male and 3 female New Zealand White rabbits at a dosage of 5000 mg/kg of body weight. The application site was occluded for 24 hours. The rabbits were observed for 14 days following application. No rabbits died during the study.

The test item produced mild or moderate erythema and no to mild oedema in the treated rabbits by approximately 24 hours. The dermal irritation in the rabbits became more severe during the study; by day 7 mild to severe erythema with slight to severe oedema, necrosis, fissuring of the skin and raw areas was observed. At study termination, mild to severe erythema with no to severe oedema, necrosis, fissuring of the skin, raw areas and epidermal scaling was still evident in the treated rabbits. Body weight losses of up to 3% of initial body weight were observed in 3 rabbits at 1 day following treatment. Under the conditions of this test, the skin absorption LD50 was greater than 5000 mg/kg of body weight.

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