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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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.