2-Butenoic acid, 4,4,4-trifluoro-3-(methylamino)-, ethyl ester, (2Z)-

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

ethyl (2Z)-4,4,4-trifluoro-3-(methylamino)but-2-enoate

EC Number:

801-277-8

Cas Number:

507448-65-9

Molecular formula:

C7H10F3NO2

IUPAC Name:

ethyl (2Z)-4,4,4-trifluoro-3-(methylamino)but-2-enoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifc des Dombes, 01400 Chatillon sur Chalaronne, France.
- Age at study initiation: Approximately 2 - 3 months.
- Weight at study initiation: 2140 - 2610 g
- Housing: Individual
- Diet: ad libitum:
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): 13 - 14/hour
- Photoperiod: 12/12 light/dark

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s): 0.5 ml
- Concentration: Neat as supplied

Duration of treatment / exposure:

4 hours

Observation period:

48 hours

Number of animals:

3 females

Details on study design:

Pre-treatment:
Approximately 24 hours before treatment, an area of approximately 10 cm wide from one flank to the other (across the back) of each animal shaved with an electric clipper.

Treatment:
The test article was applied to the shaved skin on one flank by means of a gauze patch. A control patch was applied to the other flank. The patches were loosely covered with aluminium foil and held in place with adhesive tape. Control patches were moistened with distilled water to improve
contact.

Post treatment:
4 hours after treatment, the dressings were removed and the area washed with lukewarm water to remove any remaining test article.

Scoring method:
EPA/OECD (Draize Scale)

Skin examinations:
1, 24, 48 and 72 hours after patch removal.

Clinical Observations:
Checked daily

Mortality:
Checked daily

Body weight:
Measured and recorded immediately before dose administration and at 72 hour examination (study end).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

and eschar

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

erythema score

Remarks:

and eschar

Basis:

mean

Time point:

other: 24 hours

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

erythema score

Remarks:

and eschar

Basis:

mean

Time point:

other: 48 hours

Score:

ca. 0

Max. score:

0

Results 4

Irritation parameter:

erythema score

Remarks:

and eschar

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

ca. 0

Max. score:

0

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 hours

Score:

ca. 0

Max. score:

0

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0

Max. score:

0

Irritant / corrosive response data:

Skin Examination:
Very slight erythema (score 1) was observed in one animals (no. 835) at the 1-hour and 24 hour examinations. All skin reactions were fully reversed within 48 hours.
For results see Table 1.
Calculated skin irritation indices and scores according to OECD/EEC guidelines are presented in Table 2.

Classification:
According to Commission Directive 93/21/EEC, issued May 4, 1993, the results of this test indicate that CA 2219 A (Intermediate of CGA 276854) is not required to be classified for skin irritation.

Other effects:

Mortality:
There was no mortality in the test.

Clinical Observations:
There were no remarkable clinical observations.

Body weights:
Body weights were not affected by treatment.

Any other information on results incl. tables

Table1: Individual Dermal Irritation Scores (Draize)

ANIMAL NO.	MALES
	088		043			166
	ERYTHMA AND ESCHAR
	CF	TF		CF	TF	CF	TF
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS	0 0 0 0	0 0 0 0		0 0 0 0	0 0 0 0	0 0 0 0	1 1 0 0
	EDEMA
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS	0 0 0 0	0 0 0 0		0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0
CF: CONTROL FLANK    TF: TEST FLANK

 

Table 2: Summary Dermal Irritation Scores (OCED/EEC)

ANIMAL NO.	MALES
	859	747		835
	ERTHYEMA AND ESCHAR
MEAN SCORE 24 – 72 HOURS	0		0		0.33
OVERALL MEAN SCORE 24 – 72 HOURS	0
	EDEMA
MEAN SCORE 24 – 72 HOURS	0		0		0
OVERALL MEAN SCORE 24 – 72 HOURS	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Calculation of mean scores for individual animals (EEC method, 24 – 72 hours) for erythema and eschar and resulted in scores of 0 to 0.33, with an overall mean of 0.11. All scores for edema were 0.
According to the test results, CA 2455 A (Intermediate of CGA 276854) is not required to be classified according to Commission Directive 93/21/EEC, issued May 4, 1993.

Executive summary:

A dermal irritation/corrosion was conducted with test article CA 2455 A (Intermediate of CGA 276854) (batch LOT 3). The test article (0.5 ml) was applied to the shaved skin of three rabbits for four hours under occlusive conditions. The test sites were examined for skin irritation at 1, 24, 48 and 72 hours after patch

Very slight erythema was observed in one animal after the 1 hour and 24 hour examination. All skin reactions were fully reversed within 48 hours after patch removal. There was no mortality, and there were no remarkable clinical observations. Body weights were not affected by treatment. 

 

Calculation of mean scores for individual animals (EEC method, 24 – 72 hours) for erythema and eschar and resulted in scores of 0 to 0.33, with an overall mean of 0.11. All scores for edema were 0. 

According to the test results, CA 2455 A (Intermediate of CGA 276854) is not required to be classified according to Commission Directive 93/21/EEC, issued May 4, 1993.