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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1994-12-08 to 1994-12-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
31 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 24 February 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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 2-methylprop-2-enoate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): TRIFLUOROETHYL METHACRYLATE (MATRIFE)

Test animals

Species:
rat
Strain:
other: Sprague-Dawley ICO: OFA-SD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: app. 8 weeks
- Weight at study initiation: 266±9 g (males), 218±6 g (females)
- Fasting period before study: no
- Housing: individually during treatment
- Diet (e.g. ad libitum): pelleted diet, ad libitum
- Water (e.g. ad libitum): 0.22 µm filtered water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2°C
- Humidity (%): 30-70%
- Air changes (per hr): app. 12/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5x6 cm (females), 5x7 cm (males)
- % coverage: app. 10% of the body surface
- Type of wrap if used: test substance and gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no; no residual test substance was observed at removal of the dressing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, considering the density of 1.172 g/cm³
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: clinical signs: frequently during the hours following application, and at least once a day thereafter for 14 days; mortality: frequently during the hours following application, and at least twice a day thereafter fro 14 days
- Frequency of weighing: day of administration (= day 1), days 8, 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No death occurred during the observation period.
Clinical signs:
No clinical signs and cutaneous reactions were observed during the study.
Body weight:
The body weight gain was not influenced by treatment.
Gross pathology:
Macroscopic examination of the main organs of the animals killed at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of TFMEA in rat (male/female) is >2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study according to OECD guideline 402, adopted 24 February 1987, and EU method B.3, 31 July 1992, groups of app. 8 weeks old Sprague-Dawley ICO: OFA-SD rats (5/sex) were dermally exposed to TFMEA (99.94% a.i.) as supplied for 24 hours to ca 10% of the body surface area (5x6 cm (females), 5x7 cm (males)) at a single dose of 2000 mg/kg bw.  Animals then were observed for 14 days.

No death occurred during the observation period. No clinical signs and cutaneous reactions were observed during the study. The body weight gain was not influenced by treatment. Macroscopic examination of the main organs of the animals killed at the end of the study revealed no apparent abnormalities.

Dermal LD50 combined > 2000 mg/kg bw