Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 June 2012 to 10 July 2012
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 restiction.

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.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 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: Ambient temperature, dessicated and under a nitrogen blanket.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 31 weeks
- Weight at study initiation: 4.25 to 4.50 kg
- Housing: Housed individually in plastic cages with perforated floors
- Diet: 125 g of standard laboratory rabbit diet were offered per day; a dietary supplement of hay was offered during acclimatisation until two days prior to dose instillation.
- Water: Drinking water was provided ad libitum.
- Acclimation period: 13 Weeks

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

IN-LIFE DATES: From: 29 June 2012 To: 10 July 2012

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
The test substance was administered as a single dose of 0.1 mL instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated.
Observation period (in vivo):
An initial assessment of the pain response was made immediately after instillation.
Ocular reactions to treatment were assessed 1, 24, 48, and 72 hours after treatment.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Please refer to "Any other information on materials and methods", below.

TOOL USED TO ASSESS SCORE: An opthalmoscope or pencil beam torch was available for use to facilitate inspection of the eyes.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
other: Not applicable as no corneal irritation was observed at any timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
other: Not applicable as no corneal irritation was observed at any timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
other: Not applicable as no corneal irritation was observed at any timepoint
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
other: Not applicable as no iridial irritation was observed at any timepoint
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
other: Not applicable as no iridial irritation was observed at any timepoint
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
other: Not applicable as no iridial irritation was observed at any timepoint
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no chemosis was observed at any timepoint
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no chemosis was observed at any timepoint
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable as no chemosis was observed at any timepoint
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
20
Reversibility:
other: Not applicable as no indication of conjunctival irritation was observed at any timepoint
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
20
Reversibility:
other: Not applicable as no indication of conjunctival irritation was observed at any timepoint
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
20
Reversibility:
other: Not applicable as no indication of conjunctival irritation was observed at any timepoint
Irritant / corrosive response data:
No sign of reaction to treatment was apparent in any animal at any time during the observation period.

Instillation of the test material gave rise to practically no or slight initial pain response.
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:
2-Bromo-3,3,3-trifluoropropene did not produce irritation, accordingly under the criteria Kay and Calandra (1962) it was classified as “non-irritating” to the eye and did not require labelling in accordance with the Globally Harmonised System and European Commission Regulation 1272/2008.