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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 November 2012 to 26 November 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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
Test material form:
solid: flakes
Details on test material:
- Name of test material (as cited in study report): Rikabinol HB
- Substance type: Monomer used in polymerisation
- Physical state: White flake
- Analytical purity: 95.6%
- Lot/batch No.: 7095
- Expiration date of the lot/batch: 31 December 2012
- Storage condition of test material: Room temperature, in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 38 to 41 weeks
- Weight at study initiation: 3.48 to 4.18 kg
- Housing: Each animal was housed individually in a plastic cage with perforated floors
- Diet: 125 g of a standard laboratory rabbit diet per day
- Water: drinking water was provided ad libitum
- Acclimation period: All rabbits were acclimatised to the experimental environment for a period of 15 or 24 weeks prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 16 to 20°C
- Humidity: 40 to 70%
- Air changes (per hr): No data
- Photoperiod: Lighting was controlled by means of a time switch to give 12 hours of artificial light (06:00 to 18:00 GMT) in each 24 hour period.

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mg
Duration of treatment / exposure:
Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): A single animal received an instillation of test substance which irrigated with copious quantities of physiological saline.
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Kay and Calandra

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1h
Score:
7.3
Max. score:
7.3
Reversibility:
fully reversible
Remarks on result:
other: The total mean scores according to the system of Kay and Calandra (1962)
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24h
Score:
4.7
Max. score:
4.7
Reversibility:
fully reversible
Remarks on result:
other: The total mean scores according to the system of Kay and Calandra (1962)
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48h
Score:
1.3
Max. score:
1.3
Reversibility:
fully reversible
Remarks on result:
other: The total mean scores according to the system of Kay and Calandra (1962)
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: The total mean scores according to the system of Kay and Calandra (1962)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.7
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.3

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Rikabinol HB did not require labelling in accordance with European Commission regulation 1272/2008.