[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

27.04.2009 - 5.5.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

1998

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

2004

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF Japan Agricultural Chemicals Regulation Laws Notification 12 Nousan 8147

Version / remarks:

2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Amino-5-cyano-N,3-dimethylbenzamide

Cas Number:

890707-29-6

Molecular formula:

C10H11N3O

IUPAC Name:

2-Amino-5-cyano-N,3-dimethylbenzamide

Test material form:

solid: particulate/powder

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
- Age at study initiation: Young adult, male
- Weight at study initiation: 3247g
- Housing: Animal was housed singly in stainless steel, wire-mesh cages suspended above cage boards.
- Diet: PMI® Nutrition International, LLC Certified Rabbit LabDiet® (#5322), approximately 125 g per day
- Water: Tap water, ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 30-70
- Air changes (per hr): Not recorded
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 74 mg (a weight equal to a 0.1 mL volume)

Duration of treatment / exposure:

Single administration into one eye

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

1 male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye remained unwashed after treatment

SCORING SYSTEM: Draize Scale, mean scores calculated according to EEC/GHS

TOOL USED TO ASSESS SCORE: Illumination and magnification

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Rednes

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Chemosis

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

The test substance produced 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 1, 2, or 3) in the treated eye of the rabbit. All irritation cleared in the treated eye of this rabbit by 8 days after instillation.

Other effects:

There were no body weight effects or clinical signs noted.

Any other information on results incl. tables

Table 1: Individual eye irritation scores according to Draize (1959)

	Animal number	Cornea	Iris	Conjunctiva  redness	Conjunctiva  chemosis
1 hour	39	0	1	2	3
24 hours	39	2	1	3	2
48 hours	39	2	1	3	2
72 hours	39	2	1	3	1
4 days	39	0	0	3	0
5 days	39	0	0	2	0
6 days	39	0	0	2	0
7 days	39	0	0	1	0
8 days	39	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

According to the Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, the test substance is classified as irritant and placed in Category 2A.

Executive summary:

The eye irritation potential of the test substance was evaluated according to OECD Guideline 405.

A single dose of 74 mg (equivalent to 0.1 mL) of the test substance was administered into the lower conjunctival sac of the right eye of 1 male young adult New Zealand White rabbit. The eye remained unwashed after treatment. Since severe conjunctivitis was observed, no further rabbits were treated. The conjunctiva, iris, and cornea of the treated eye were evaluated for evidence of irritation approximately 1, 24, 48, and 72 hours and up to 8 days following administration of the test substance.
The test substance produced 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 1, 2, or 3) in the treated eye of the rabbit. All irritation cleared in the treated eye of this rabbit by 8 days after instillation.

According to the Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, the test substance is classified as irritant and placed in Category 2A.