Ethyl trichloroacetate

Skin irritation / corrosion

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:

guideline study

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

application: 3 min

Time point:

24/48/72 h

Score:

1.1

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

, application: 3 min

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

, application: 3 min

Time point:

24/48/72 h

Score:

1

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

, application: 3 min

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

application: 4 h

Time point:

24/48/72 h

Score:

2.1

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

, application: 4 h

Time point:

24/48/72 h

Score:

2

Max. score:

4

Remarks on result:

other: not identical with animal #1, application 3 min

Results 7

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

, application: 4 h

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Remarks on result:

other: not identical with animal #2, application 3 min

Results 8

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

application: 4 h

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Remarks on result:

other: not identical with animal #3, application 3 min

Results 9

Irritation parameter:

edema score

Basis:

mean

Remarks:

application: 3 min

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Results 10

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

, application: 3 min

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Results 11

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

, application: 3 min

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

, application: 3 min

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

edema score

Basis:

mean

Remarks:

application: 4 h

Time point:

24/48/72 h

Score:

1.4

Max. score:

4

Results 14

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

, application: 4 h

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Remarks on result:

other: not identical with animal #1, application 3 min

Results 15

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

, application: 4 h

Time point:

24/48/72 h

Score:

2

Max. score:

4

Remarks on result:

other: not identical with animal #2, application 3 min

Results 16

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

, application: 4 h

Time point:

24/48/72 h

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:

Category 2 (irritant) based on GHS criteria

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.