Tetrachloroethylene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

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other: Guideline study, GLP status not reported, available as unpublished report, fully adequate for assessment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

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Tetrachloroethylene

EC Number:

204-825-9

EC Name:

Tetrachloroethylene

Cas Number:

127-18-4

Molecular formula:

C2Cl4

IUPAC Name:

tetrachloroethene

Details on test material:

- Name of test material (as cited in study report): tetrachloroethylene- Analytical purity: > 99.95%- Composition of test material, percentage of components: stabilized with ionol (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 or test system 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 daysENVIRONMENTAL 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 ionol

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 expsoure period

Number of animals:

Experiment 1 (tetrachloroethylene tested individually): 3Experiment 2 (tetrachloroethylene 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 hoursSCORING SYSTEM:Method of Draize et al. (1944)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours after the application

Score:

4

Max. score:

4

Reversibility:

other: at day 16, the mean score was 1.3

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours, 9 and 16 days after the application

Score:

1.7

Max. score:

4

Reversibility:

other: at day 16, the mean score was 0.7

Results 3

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

Time point:

other: 24, 48 and 72 hours after application

Score:

5.7

Remarks on result:

other: Experiment 1 (tetrachloroethylene tested individually): 3

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours after the application

Score:

4

Max. score:

4

Reversibility:

other: at day 16, the mean score was 0.7. After five weeks all effects had cleared completely.

Remarks on result:

other: tetrachloroethylene examined simultaneously with three other solvents on separate skin areas

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours, 9 and 16 days after the application

Score:

1.9

Max. score:

4

Reversibility:

other: at day 16, the mean score was 0.3. After five weeks all effects had cleared completely.

Remarks on result:

other: tetrachloroethylene examined simultaneously with three other solvents on separate skin areas

Results 6

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

Time point:

other: 24, 48 and 72 hours after application

Score:

5.9

Remarks on result:

other: Experiment 2 tetrachloroethylene examined simultaneously with three other solvents on separate skin areas

Irritant / corrosive response data:

Experiment 1:Generally the following skin reactions were observed at one or more observation time points, up to 72 hours after treatment: well-defined erythema, very slight or slight oedema, very slight ischemic necrosis (not after 4 hours) and very slight incrustation (after 72 hours only).After 9 days well-defined erythema, very slight oedema and moderate scaliness (in all three rabbits) and very slight incrustation (in two rabbits) were reported.After 16 days very slight or well-defined erythema (in all three rabbits) and slight oedema (in one rabbit) were observed.Experiment 2: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 well-defined erythema, very slight or slight oedema (in all three rabbits), slight or severe scaliness (in two rabbits) and moderate incrustation (in one rabbit) were reported.After 16 days very slight or well-defined erythema (in all three rabbits), very slight oedema (in two rabbits) and decreased hair growth (in one rabbit) were observed.After five weeks all effects had cleared completely.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

According to CLP criteria (mean value of ≥2,3 - ≤4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal) the substance shall be classified as Skin Irrit. Category 2, H315: causes skin irritation.

Executive summary:

A skin irritation in rabbits is avaialble according to OECD guideline No. 404 and conducted under GLP (Van Beek, 1990). Two groups of 3 New Zealand White rabbits were treated with a substance of > 99.95 % purity stabilized with ionol (concentration 10 mg/l). 0.5 ml of the test material was applied as an occlusive coverage on a shaved skin for 4 hours. After exposure the test material was washed up with a warm water and soap. Skin reactions were scored by the method of Draize (1944) at 1, 24, 48, 72 hours, 9 and 16 days after the exposure. Well-defined erythema was observed 24, 48, 72 hours after the application (mean score “4”) which was not fully reversed at day 16. Other skin reactions (oedema – mean score 1.7-1.9, ischemic necrosis, incrustation, scaliness) were from slight to moderate at different time points. According to CLP criteria (mean value of ≥2,3 - ≤4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal) the substance shall be classified as Skin Irrit. Category 2, H315: causes skin irritation.