2,2,2-trifluoroethyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1985-05-08 to 1985-05-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2,2-trifluoroethyl methacrylate

EC Number:

206-525-3

EC Name:

2,2,2-trifluoroethyl methacrylate

Cas Number:

352-87-4

Molecular formula:

C6H7F3O2

IUPAC Name:

2,2,2-trifluoroethyl methacrylate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): MATRIFE

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.44 -3.01 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): standard laboratory diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5±1.5°C
- Humidity (%):50-55%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: patches were held in place with Sleek adhesive strapping; elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, any residual test material was removed by gently swabbing cotton wool soaked in ether
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize (OECD 404)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritating effects were noted in any animal during the observation period.

Any other information on results incl. tables

Rabbit number	reaction	1/24/48/72h
1	erythema	0/0/0/0
	edema	0/0/0/0
2	erythema	0/0/0/0
	edema	0/0/0/0
3	erythema	0/0/0/0
	edema	0/0/0/0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

TFMEA was not irritating to rabbit skin in this study.

Executive summary:

In a primary dermal irritation study according to OECD guideline 404, 3 young adult New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted TFMEA (purity not given in the study report, but according to sponsor >90%) for 4 h hours to 6.25 cm² body surface area. Animals then were observed for 3 days.  Irritation was scored by the method of Draize.

No irritating effects were noted in any animal during the observation period.

In this study, TFMEA is not a dermal irritant.