Ametryn

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in compliance with guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ametryn

EC Number:

212-634-7

EC Name:

Ametryn

Cas Number:

834-12-8

Molecular formula:

C9H17N5S

IUPAC Name:

N2-ethyl-6-(methylsulfanyl)-N4-(propan-2-yl)-1,3,5-triazine-2,4-diamine

Details on test material:

Batch Identification: FLC41 050
Product design Code: G34162
Product Common Name: Ametryn
Purity: 97.7% (wt/wt)
Appearance: white powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Age: Young adult.
Source: Received from Robinson Services, Inc. Clemmons, NC on August 25, 2004.

Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature Range: 18-22°C
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 14 days
Food: Pelleted Purina Rabbit Chow #5326
Water: Filtered tap water was supplied ad-libitum by automatic water dispensing system.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analyses of the food and water are conducted at least once a year and the records are kept on file at Product Safety Laboratories.

Cage: Each cage was identified with a cage card indicating at least the study number and identification and sex of the animal.
Animal: A number was allocated to each rabbit on receipt and a stainless steel ear tag bearing this number was attached to the animal. This number constituted unique identification.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Test substance amount: 0.02 grams
Prior to use, the test substance was ground with a mortar and pestle.

Duration of treatment / exposure:

One-tenth of a milliliter (0.02 grams) of the test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control. The rabbits were then returned to their designated cages.

Observation period (in vivo):

1, 24, 48, and 72 hours

Number of animals or in vitro replicates:

3 Female, nulliparous and non-pregnant.

Details on study design:

Ocular irritation was evaluated using a high-intensity white light (Mag Lite) in accordance with Draize et al.. The fluorescein dye evaluation was used at 24 hours and as needed at subsequent scoring intervals to evaluate the extent or verify the absence of corneal damage. In addition to observations of the cornea, iris and conjunctivae, any other observed lesions were noted. The average score for all rabbits at each scoring period was calculated to aid in data interpretation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48, 72, hrs

Score:

0.23

Max. score:

4

Reversibility:

fully reversible

Remarks:

24 hrs

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48, 72, hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1, 24, 48, 72, hrs

Score:

0.57

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1, 24, 48, 72, hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1, 24, 48, 72, hrs

Score:

4

Reversibility:

fully reversible

Remarks:

72 hrs

Irritant / corrosive response data:

All animals appeared active and healthy. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

Within 24 hours after test substance instillation, corneal opacity was observed in one treated eye. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation within 72 hours.

The Maximum Mean Total Score of Ametryn Technical is 4.0.

Other effects:

no data

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU