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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:
key study
Study period:
11 March 2012 - 23 March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to EC and OECD test guidelines and in compliance with GLP; on this basis the result is considered reliable without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):2-Bromo-3,3,3-trifluoropropene
- Physical state: Clear liquid with slight yellow tint
- Analytical purity: 99.9%
- Lot/batch No.: KgF080
- Expiration date of the lot/batch: 01 August 2012
- Storage condition of test material: Refrigerator (nominally +4°C)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 35 or 36 weeks
- Weight at study initiation: 3.55 - 4.94 kg
- Housing: Housed individually in plastic cages with perforated floors
- Diet: Animals were provided with 125 g of standard laboratory rabbit diet per day. A dietary supplement of hay was also available.
- Water: Free access to drinking water
Acclimatisation: At least ten weeks prior to study start

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 20°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light : 12 hours dark

IN-LIFE DATES: From: 11 March 2012 To: 23 March 2012

Test system

Type of coverage:
occlusive
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:
3 minutes, one hour, and four hours (intial animal, received three exposures).
Four hours (2 animals).
Observation period:
72 hours (observations made at 1, 24, 48, and 72 hours)
Number of animals:
3
Details on study design:
TEST SITE
25 mm x 25 mm gauze pad, covered with a square peice of aluminium foil (55 mm x 55 mm), sealed with impermeable surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the dressing and gauze pad were removed and the treatment site was washed with lukewarm water (30 - 40°C) to remove any residual test substance. The treatment area was blotted dry with absorbent paper.

SCORING SYSTEM:
Refer to "Any other information on materials and methods", below.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no erythema was seen in any animal
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no erythema was observed at any timepoint
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no erythema was observed at any timepoint
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no oedema was seen at any timepoint
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no oedema was seen at any timepoint
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no oedema was seen at any timepoint
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal reaction was observed in any animal throughout the duration of the study.
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria of the Globally Harmonised System and European Commission regulation 1272/2008 2-Bromo-3,3,3-trifluoropropene did not produce irritation or corrosivity and did not require any classification and labelling.