Methyl trifluoroacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from NTRL reports

Data source

Reference

Reference Type:

secondary source

Title:

INITIAL SUBMISSION: LOCAL TOLERANCE TEST IN RABBITS-CUTANEOUS PRIMARY IRRITATION –OCCULAR IRRITATION OF METHYL TRIFLUROACETATE IN RABBITS WITH COVER LITTER DATED 101692

Author:

NTRL reports

Year:

1992

Bibliographic source:

OTS0571344, NTRL report, last updated 1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To assess the dermal irritation potential of methyl trifluoroacetate in rabbits according to OECD 404 Guidelines

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Methyl trifluoroacetate

EC Number:

207-074-5

EC Name:

Methyl trifluoroacetate

Cas Number:

431-47-0

Molecular formula:

C3H3F3O2

IUPAC Name:

methyl 2,2,2-trifluoroacetate

Test material form:

liquid

Details on test material:

- Name of the test chemical: methyl trifluoroacetate
- Molecular formula: C3H3F3O2
- Molecular weight: 128.05 g/mol
- Smiles notation: O=C(OC)C(F)(F)F
- InChl: 1S/C3H3F3O2/c1-8-2(7)3(4,5)6/h1H3
- Substance type: Organic
- Physical state: Liquid

Specific details on test material used for the study:

- Name of the test chemical: methyl trifluoroacetate
- Molecular formula: C3H3F3O2
- Molecular weight: 128.05 g/mol
- Smiles notation: O=C(OC)C(F)(F)F
- InChl: 1S/C3H3F3O2/c1-8-2(7)3(4,5)6/h1H3
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- sex: Male
- Source: Charles river
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (200g)
- Fasting period before study: no data
- Housing: The rabbits were kept in individual polystyrene cages, measuring 540×360×315mm with a perforated polystyrene flour in ventilated and air conditioner room.
- Diet (e.g. ad libitum): 150gm of complete maintenance food (granules Lapin Entration “112” UAR, 91360 – Villemoisson/Drge) is provided per rabbit per day.
- Water: ad libitum (softened and filtered water-15 µ)
- Acclimation period: 8 days
Rabbits were vaccinated against Myxomatosis (Lyomyxovax, institut Merleux)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12 to 14 times per hours (pre-filtered air: 5- 10 µ)
- Photoperiod (hrs dark / hrs light): artificial lighting for 12 hrs (7.30am to 7.30pm)

IN-LIFE DATES: From: To: No data available

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

24,48, 72 hours.The observation period may be extended to 7 or 14 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: whole clipped surface (back 14cm×14cm)
- % coverage:6 square centimeter area
- Type of wrap if used: bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): If necessary the excess of the test substance which has not penetrated, the gauze pad moisten with deionized water (or non-irritant solvent)
- Time after start of exposure: No data available

SCORING SYSTEM: The mean values for erythema and edema were calculated for 6 rabbits examined at 1,24,48 and 72 hours after removal of the semi occlusive patches.
The cutaneous reactions were scored according to the following scale:
Erythema or Eschar formation:
no erythema =0
very slight erythema(barely perceptible) = 1
well defined erythema = 2
moderate to severe erythema = 3
severe erythema [beet redness] to slight eschar formation [injuries in depth] = 4
Edema formation:
No edema formation = 0
very slight edema(barely perceptible) = 1
slight edema [edges well defined by definte raising] = 2
moderate edema [edges raised approx 1mm] = 3
severe edema [raised more than 1mm and extending the area of exposure] = 4

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hr

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hr

Score:

0.17

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 and 72hr

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hr

Score:

0.17

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The mean score for erythema and edema formation after 72 hours was 0.06 and 0.00 respectively

Any other information on results incl. tables

Table 1: Evaluation of cutaneous irritation potential after removal of patches

Rabbit number		1263	1264	1265	1266	1267	1268	Total	Mean
Erythema	1 hour	1	1	0	0	0	0	3	0.50
	24 hours	0	1	0	0	0	0	1	0.17
	48 hours	0	0	0	0	0	0	0	0
	72 hours	0	0	0	0	0	0	0	0
					Erythema mean = 24+48+72 hours				0.06

 

Rabbit number		1263	1264	1265	1266	1267	1268	Total	Mean
Edema	1 hour	0	1	0	0	0	0	1	0.17
	24 hours	0	0	0	0	0	0	0	0
	48 hours	0	0	0	0	0	0	0	0
	72 hours	0	0	0	0	0	0	0	0
					Edema mean = 24+48+72 hours				0.00

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The mean score for erythema and edema formation after 72 hours was 0.06 and 0.00 respectively.
Based on the scores, methyl trifluoroacetate can be considered not irritating to rabbit skin.

Executive summary:

The dermal irritation potential of methyl trifluoroacetate was assessed in rabbits. The study was performed according to OECD 404 Guidelines. Six male albino New Zealand rabbits were used for the study. The six rabbits are carefully clipped on the back and on the flanks with a fine toothed electronic clipper (Asaculap – type V 42 947), to bare a surface 14cm×14cm (cutting height: 1/20^thmm). The skin must be perfectly clean shaven often clipping. 0.5 ml of the undiluted sterile test substance was applied with a sterile polypropylene syringe(Becton Dickson) of 2 ml, on a Codex hydrophilic eight layer gauze pad, about 2.5 square cms. The test substance and the gauze pad are held in contact with the skin using a semi- occlusive patch: 10 cm wide adhesive perforation tape applied on a crimped gauze covering the whole clipped surface and wrapped around the animal. The test substance is kept in contact with the skin for 4 hours and the animals are retained in plastic restrainers. After 4 hours the patches were removed and the excess material was wiped with a gauze pad moistened with deionized water. The animals were observed for signs of irritation (erythema and edema formation) 1, 24, 48 and 72 hours after patch removal. The observation may be extended to 7 or 14 days to determine the corrosive nature of the test chemical.

The mean score for erythema and edema formation after 72 hours was 0.06 and 0.00 respectively.

Based on the scores, methyl trifluoroacetate can be considered not irritating to rabbit skin.