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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP status not reported, available as unpublished report, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trichloroethylene
- Analytical purity: > 99.95%
- Composition of test material, percentage of components: stabilized with thymol (10 mg/l)
- Storage condition of test material: packed in dark coloured glass bottles and stored at room temperature until use.
- Other: Due to the low levels of stabilizer added to the solvents degradation may occur in contact with light metals, especially aluminium. Contact of the test material with metals was prevented at all times, before and during the experiments.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, The Netherlands
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: individually, suspended, galvanized cages, fitted with a wire-mesh floor and front.
- Diet: ad libitum
- Water: ad libitum
- Acclimatization period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): >40
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: stabilized with thymol
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 10 mg/l
Duration of treatment / exposure:
4 hours
Observation period:
at 1, 24, 48, 72 hours, 9 and 16 days after the 4 hour exposure period
Number of animals:
Experiment 1 (trichloroethylene tested individually): 3
Experiment 2 (trichloroethylene examined simultaneously with three other solvents on separate skin areas): 3
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- Type of wrap if used: patches fixed to the application sites by means of adhesive tape and the entire trunk of each rabbit was wrapped with an impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water and soap
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Method of Draize et al. (1944)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours after application
Score:
4
Max. score:
4
Reversibility:
other: at day 16, the mean score was 0.3
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours after application
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 16 days
Irritation parameter:
overall irritation score
Basis:
other: The Primary Irritation Index was calculated by combining the scores for erythema/eschar formation and oedema after 24, 48 and 72 hours.
Time point:
other: 24, 48 and 72 hours after application
Score:
5.5
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours after application
Score:
3.8
Max. score:
4
Reversibility:
other: At day 16, the mean score was 0.3
Remarks on result:
other: trichloroethylene examined simultaneously with three other solvents on separate skin areas
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours after application
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 16 days
Remarks on result:
other: trichloroethylene examined simultaneously with three other solvents on separate skin areas
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: The Primary Irritation Index was calculated by combining the scores for erythema/eschar formation and oedema after 24, 48 and 72 hours.
Time point:
other: 24, 48 and 72 hours after application
Score:
5.4
Remarks on result:
other: trichloroethylene examined simultaneously with three other solvents on separate skin areas
Irritant / corrosive response data:
Experiment 1 (rabbits treated with only one test substance):
Generally the following skin reactions were observed at one or more obervation time points, up to 72 hours afer treatment: well-defined erythema, very slight or slight ischemic necrosis (not after 4 hours) and very slight incrustation (after 72 hours only).
After 9 days, very slight erythema (in two rabbits) and very slight oedema, slight or severe scaliness and very slight, slight or moderate incrustation (in all three rabbits); after 16 days, very slight erythema (in one rabbit).

Experiment 2 (rabbits treated with four test substances at the same time):
Generally the following skin reactions were observed at one or more observation time points, up to 72 hours after treatment: well-defined or moderate erythema, very slight or slight oedema, very slight ischemic necrosis (not after 4 hours) and slight scaliness or slight incrustation (mainly after 72 hours).
After 9 days, very slight or well-defined erythema (in two rabbits), very slight or slight oedema (in all three rabbits), severe scaliness (in one rabbit) and moderate incrustation (in all three rabbits). After 16 days: very slight erythema (in one rabbit) and decreased hair growth (in two rabbits).
After five weeks all effects had cleared completely.

Applicant's summary and conclusion