Ethyl trifluoroacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed similarly to OECD guideline with some restrictions (6 animals instead of 3. No data on the age of the animals at the beginning) and no compliance with the GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other 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:

: 6 animals instead of 3. No data on the age of the animals at the beginning

Principles of method if other than guideline:

not applicable

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl trifluoroacetate

EC Number:

206-851-6

EC Name:

Ethyl trifluoroacetate

Cas Number:

383-63-1

Molecular formula:

C4H5F3O2

IUPAC Name:

ethyl 2,2,2-trifluoroacetate

Details on test material:

- Name of test material (as cited in study report): Trfluoroacétate d'éthyle
- Physical state: incolor liquid
- Stability under test conditions: no data. Assume to be stable (sponsor responsibility)
- Storage condition of test material: no data
- Other: pH measurement was impossible (instable measure)

Test animals

Species:

rabbit

Strain:

other: Albino New-Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Roucher (86700, Couhé); EGAV (61350 Passais la conception); Elevage scientifique des Dombes (01400 Chatillon sur Chalaronne); Gwen Meur (22200 Trégonneau)
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (+/- 200 g)
- Housing: individual polystyrene cages (540 x 360 x 315 mm) with a perforated polystyrene floor.
- Diet (e.g. ad libitum): 150 g of complete maintenance food (granulés lapin Entretien "112" UAR, 91360 Villemoisson/Orge) is provided per rabbit and per day.
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: yes for 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 times per hour
- Photoperiod (hrs dark / hrs light): 12hrs / 12 hrs

IN-LIFE DATES: From: To: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Remarks:

the test item is applied on the skin as supplied by the sponsor

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable

VEHICLE
not applicable

Duration of treatment / exposure:

4h

Observation period:

1h, 24, 48 and 72 hrs after the removal of the patch. The observation time may be extended (maximum 14 days) in order to show an eventual corrosive action of the test item, characterized by the irreversibility of the lesions observed.

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: the flanks
- % coverage: 2.5 cm²
- Type of wrap if used: the gauze pad is held in contact with the skin with a semi-occlusive patch: 4 cm wide adhesive tape, applied on a hydrophilic gauze pad (20 cm x 15 xm) covering the whole clipped surface and wound arounbd the animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess of the test item which has not penetrated is wiped with a gauze pad moistened with deionized wtaer (or a non-irritant solvent).
- Time after start of exposure: 4h

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: overall 24, 48, 72h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: erythema larger than the application site area

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: overall 24, 48, 72h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: overall 24, 48, 72h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

mean individual score

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

mean individual score

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

mean individual score

Time point:

other: overall 24, 48, 72h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

of the 6 animals score

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

primary dermal irritation index (PDII)

Score:

0.71

Max. score:

8

Remarks on result:

other: slightly irritating

Irritant / corrosive response data:

Ethyl trifluoroacetate is slightly irritating to the skin but these effects are fully reversible (see details in Table 7.3.1/1).

Other effects:

no data

Any other information on results incl. tables

Table 7.3.1/1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (4h)

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	2^$/0/1/1/1^$/1	0/0/0/0/0/0
24 h	2^$/0/1/0/0/1	0/0/0/0/0/0
48 h	2^$/1/1/0/0/0	0/0/0/0/0/0
72 h	2^$/1/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	1.83	0.0
Reversibility*)	c	-
Average time (day) for reversion**	7	-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

**): correspond to the last day for which skin irritation signs in the last animal were observed

^$) : erythema larger than the application site area

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, Ethyl trifluoroacetate is not classified as skin irritant when applied topically to rabbits according to the Annex I of the Regulation (EC) 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EEC.

Executive summary:

In a dermal irritation study performed in a similar manner to the OECD guideline No. 404, 6 male New Zealand Albino rabbits, were dermally exposed to 0.5 mL of undiluted Ethyl trifluoroacetate (purity of 97.3%) to the clipped skin of the flank.Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 14 days for edema and erythema. 

Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch.  

The mean scores calculated within 3 scoring times (24, 48 and 72 hrs) were 1.83 for erythema and 0.0 for edema among the six animals.

Under the test conditions, the test item Ethyl trifluoroacetate is not classified as skin irritant when applied topically to rabbits according to the Regulation (EC) 1272/2008 (CLP) and to the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.