Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MAFF Japan Agricultural Chemicals Regulation Laws Notification 12 Nousan 8147 (2000)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate
EC Number:
601-478-9
Cas Number:
117428-22-5
Molecular formula:
C18H16F3NO4
IUPAC Name:
methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate
Test material form:
solid
Details on test material:
Purity: 99.66%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Weight at study initiation: 2555 g
- Housing: The animal was housed singly in a stainless steel, wire-mesh cage suspended above a cage board.
- Diet: approximately 125 grams/day
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16-22°C
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: Approximately 59 mg (a weight equal to a 0.1 mL volume) of test substance
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
1 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
The treated and control eye remained unwashed following treatment.

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Other effects:
Fluorescein stain examination of the treated eye was positive for corneal injury at 24 hours after instillation of the test substance.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Mildly irritant
Executive summary:

The test substance was evaluated for acute eye irritation potential in 1 young adult New Zealand White rabbit. A skin irritation study was previously conducted. The test substance was not a severe skin irritant or corrosive to the skin.

One rabbit was initially treated. Since severe irritation was observed, no further rabbits were treated. Approximately 59 mg (a weight equal to a 0.1 mL volume) of test substance was administered to 1 eye of the animal. The treated and control eye remained unwashed following treatment. The conjunctiva, iris, and cornea of the treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours and 7 days following administration of the test substance.

Corneal opacity (score of 2), iritis (score of 1), conjunctival redness (score of 1, 2, or 3), conjunctival chemosis (score of 1, 2, or 3), and discharge (score of 2) were observed in the treated rabbit eye. Fluorescein stain examination of the treated eye was positive for corneal injury at 24 hours after instillation of the test substance. The treated eye of the rabbit was normal by 7 days after instillation.

No clinical signs of toxicity were observed, and no body weight loss occurred in the rabbit. Mean values were calculated for the animal by using numerical scores obtained from the quantitative evaluation of each ocular response observed approximately 24, 48, and 72 hours following treatment.

These values are as follows:

Corneal opacity: 0.67

Iritis: 1

Conjunctival redness: 2.67

Conjunctival chemosis: 1.33