Registration Dossier

Diss Factsheets

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: The study was conducted according to GLP and valid testing guidelines, therefore it is considered relevant, adequate and reliable for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
evaluation after 3 minutes and 4 hours exposure
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl trichloroacetate
EC Number:
208-212-7
EC Name:
Ethyl trichloroacetate
Cas Number:
515-84-4
Molecular formula:
C4H5Cl3O2
IUPAC Name:
ethyl 2,2,2-trichloroacetate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Ethyl trichloroacetate; Trichloressigsäureethylester; Ethyltricloracetat; Trichlorethansäureethylester
- Substance type: Organic monoconstituent substance
- Physical state: Colourless, clear liquid
- Analytical purity: 98.9%
- Purity test date: COA: no. 07960 dd 2003-08-16
- Lot/batch No.: Op. 165, manufactured: 2003-08-14 by Hoechst AG (now: CABB GmbH)
- Storage condition of test material: At 4°C in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: raised by Hoechst AG, site Hattersheim-Kastengrund near Frankfurt am Main, Germany
- Weight at study initiation: 3.1-3.7 kg
- Diet (e.g. ad libitum): Altromin 2123 Haltüngsdiät-Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum
- Water (e.g. ad libitum): deionized, chlorinated water from automatic watering, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2°C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of the test substance, undiluted
Duration of treatment / exposure:
3 min or 4 h, respectively
Observation period:
72 h - extended to 7 days or 14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsolateral area of the trunk
- % coverage: 6.25 cm2 (2.5 X 2.5 cm)
- Type of wrap if used: cellulose adhesive plaster covered with a semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining test item was gently removed from the skin.
- Time after start of exposure: 3 minutes or 4 hours respectively

SCORING SYSTEM:
Numerical scores according to Draize

Erythema and Eschar
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slicht eschar formation (injuries in depth)

Edema
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well-defined by definite raising)
3: Moderate edema ( raise approximately 1 mm)
4: Severe edema (raised more than 1 mm, extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
application: 3 min
Time point:
other: 24, 48 and 72 h (mean score)
Score:
1.1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, application: 3 min
Time point:
other: 24, 48, 72 h (mean score)
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
, application: 3 min
Time point:
other: 24, 48, 72 h (mean score)
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
, application: 3 min
Time point:
other: 24, 48, 72 h (mean score)
Score:
0.3
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
application: 4 h
Time point:
other: 24, 48 and 72 h (mean score)
Score:
2.1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, application: 4 h
Time point:
other: 24, 48, 72 h (mean score)
Score:
2
Max. score:
4
Remarks on result:
other: not identical with animal #1, application 3 min
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
, application: 4 h
Time point:
other: 24, 48, 72 h (mean score)
Score:
2.7
Max. score:
4
Remarks on result:
other: not identical with animal #2, application 3 min
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
application: 4 h
Time point:
other: 24, 48, 72 h (mean score)
Score:
1.7
Max. score:
4
Remarks on result:
other: not identical with animal #3, application 3 min
Irritation parameter:
edema score
Basis:
mean
Remarks:
application: 3 min
Time point:
other: 24, 48 and 72 h (mean score)
Score:
0.2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, application: 3 min
Time point:
other: 24, 48, 72 h (mean score)
Score:
0.7
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
, application: 3 min
Time point:
other: 24, 48, 72 h (mean score)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
, application: 3 min
Time point:
other: 24, 48, 72 h (mean score)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
application: 4 h
Time point:
other: 24, 48 and 72 h (mean score)
Score:
1.4
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, application: 4 h
Time point:
other: 24, 48, 72 h (mean score)
Score:
1.3
Max. score:
4
Remarks on result:
other: not identical with animal #1, application 3 min
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
, application: 4 h
Time point:
other: 24, 48, 72 h (mean score)
Score:
2
Max. score:
4
Remarks on result:
other: not identical with animal #2, application 3 min
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
, application: 4 h
Time point:
other: 24, 48, 72 h (mean score)
Score:
1
Max. score:
4
Remarks on result:
other: not identical with animal #3, application 3 min
Irritant / corrosive response data:
At an exposure time of 3 minutes, very slight to well-defined erythema and barely perceptible edema were observed. No signs of irritation were observed 7 days after application. The skin was merely still dry, brittle or fine-to-rough scaly and in one animal small areas with brownish discoloration were observed.
At an exposure time of 4 hours well-defined to moderate erythema and edema were observed. 14 days after application, the treated skin showed no more irritation. The skin was also dry, brittle, fine-to-rough scaly and brownish.

Any other information on results incl. tables

Table 1. Mean values for observations at 24, 48 and 72 hours

 

 

Exposure

3 minutes

4 hours

Erythema and Eschar formation

All animals

1.1

2.1

Animal 1

2.0

2.0

Animal 2

1.0

2.7

Animal 3

0.3

1.7

Edema

All animals

0.2

1.4

Animal 1

0.7

1.3

Animal 2

0

2.0

Animal 3

0

1.0

 

Table 2. Individual values after 3 minutes exposure to Ethyl Trichloroacetate

Time after removal of patch

0.5-1 hour

24 hours

48 hours

72 hours

7days

14 days

Animal No.

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

Erythema

2

0

1

2

1

1

2

1

0

2

1

0

0

0

0

 

 

 

Edema

1

0

0

1

0

0

1

0

0

0

0

0

0

0

0

 

 

 

Skin surface

 

-dry,brittle

 

 

 

 

 

 

 

 

 

 

 

 

x

x

x

 

 

 

-fine scaly

 

 

 

 

 

 

 

 

 

 

 

 

x

x

x

 

 

 

-rough scaly

 

 

 

 

 

 

 

 

 

 

 

 

x

x

x

 

 

 

Skin discoloration

 

-small areas, brownish

 

 

 

 

 

 

 

 

 

 

 

 

x

 

 

 

 

 

 

Table 3. Individual values after 4 hours exposure to Ethyl Trichloroacetate

Time after removal of patch

0.5-1 hour

24 hours

48 hours

72 hours

7days

14 days

Animal No.

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

Erythema

2

2

2

2

2

2

2

3

2

2

3

1

0

1

0

0

0

0

Edema

3

3

2

2

2

2

1

2

1

1

2

0

0

1

0

0

0

0

Skin surface

 

-dry,brittle

 

 

 

 

 

 

 

 

 

 

 

x

x

x

x

 

 

 

-fine scaly

 

 

 

 

 

 

 

 

 

 

 

x

x

x

x

x

x

 

-rough scaly

 

 

 

 

 

 

 

 

 

 

 

 

x

 

 

 

x

 

Skin discoloration

 

-small areas, brownish

 

 

 

 

x

 

x

x

 

x

x

 

 

x

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information application: 4h Criteria used for interpretation of results: EU
Conclusions:
According to the classification criteria of the EC Directive and taking into account all relevant toxicological findings, the test substance Ethyl trichloroacetate can be described as an irritant at an exposure time of 4 hours.
Executive summary:

Acute dermal irritation was tested in 6 New Zealand White rabbits according to OECD guideline 404. Twenty-four hours before application, a dorsolateral area of the trunk (ca. 25 cm2)of 3 rabbits was shaved. Only animals with an intact skin were used for testing.
0.5 mL undiluted test item was applied on 2.5 x 2.5 cm cellulose adhesive plaster. The plaster was fixed on the shaved area and covered with a semi-occlusive bandage. Exposure time was 3 minutes and 4 hours respectively. After exposure, the remaining test item was gently removed from the skin. Examinations were performed 30-60 minutes and 24, 48 and 72 hours after removal of the plaster. Additional examinations were done after 7 and (in 3 animals) after 14 days, because of findings after 72 hours. Erythema and edema were numerically scored after Draize. All other toxicological significant findings were recorded.

At an exposure time of 3 minutes, very slight to well-defined erythema and barely perceptible edema were observed. No signs of irritation were observed 7 days after application. The skin was merely still dry, brittle or fine-to-rough scaly and in one animal small areas with brownish discoloration were observed.

At an exposure time of 4 hours well-defined to moderate erythema and edema were observed. Mean 24 -72h scores were 1.1/ 4 (3') and 2.1/4 (4h) for erythema and 0.2/4 (3') and 1.4/4 (4h) for edema.14 days after application, the treated skin showed no more irritation. The skin was also dry, brittle, fine-to-rough scaly and brownish.

Accordingto the classification criteriaof the EC Directiveandtaking into account allrelevant toxicological findings, the test substance Ethyl trichloroacetate can be described as an irritant at an exposure time of 4 hours.