1,3,5-Triazine-2,4-diamine, N2,N2,N4,N4-tetrabutyl-6-chloro-

Eye irritation

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:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Version / remarks:

1985

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Terbuthylazine

EC Number:

227-637-9

EC Name:

Terbuthylazine

Cas Number:

5915-41-3

Molecular formula:

C9H16ClN5

IUPAC Name:

N-tert-butyl-6-chloro-N'-ethyl-1,3,5-triazine-2,4-diamine

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: white powder
- 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: Bancel (Albon - 26l40 Saint Rambert d'Albon - France
- Age at study initiation: adult males
- Weight at study initiation: 2.35-2.5 kg
- Housing: individually housed in polystyrene cages, with perforated flooring (interior dimensions 56O x 355 x 315 nim)
- Diet: approximately 150 g per animal and per day of complete pelleted rabbit maintenance diet (U.A.R. formule 112 - U.A.R,, Villemoisson - 91360 Epinay-S/Orge 7 France).
- Water: softened and filtered (5 µm) mains drinking water ad libitum (automatic dispenser)
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 to 30°C
- Humidity: 30 to 60 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

52 mg per animal of the test article as supplied (corresponding to 0.1 ml volume) into the inferior conjunctival sac of the right eye of each of the 6 rabbits by means of a transparent plastic tube.

Duration of treatment / exposure:

24 hours. The eyes were rinsed after this period, to provide evidence of any possible corneal erosion with the aid of fluorescein which was eliminated with water.

Observation period (in vivo):

To perform the ocular examinations the animals were immobilised on a table. These examinations were always performed under the same conditions in particular with reference to the ambient lighting. Ocular examinations were performed 1 hour after administration of the test article, then at 24, 48 and 72 hours.

Number of animals or in vitro replicates:

6 male animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

SCORING SYSTEM: OECD Guideline

TOOL USED TO ASSESS SCORE: Examination of the cornea, iris and pupil was performed with the aid of a Heine ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects recorded

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

2

Reversibility:

fully reversible within: 72h

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

not fully reversible within: 72h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48h

Other effects:

No mortality was noted. There were no changes in behaviour or clinical signs in any of the treated animals during the 3 days of the observation period.

Any other information on results incl. tables

OVERVIEW OF RESULTS

		Animal 1	Animal 2	Animal 3	Animal 4	Animal 5	Animal 6
erythema	1 h	2	1	2	2	2	2
	24 h	2	2	1	2	1	1
	48 h	1	0	0	1	0	0
	72 h	0	0	0	1	0	0
chemosis	1 h	1	1	1	1	1	1
	24 h	1	1	0	1	0	1
	48 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0
cornea	1 h	0	0	0	0	0	0
	24 h	0	0	0	0	0	0
	48 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0
Iris	1 h	1	1	1	1	1	1
	24 h	1	0	1	1	1	1
	48 h	0	0	1	1	0	1
	72 h	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, from the results obtained under the experimental conditions, administration of this test article into the rabbit's eye can be designated as NON-IRRITANT.

Executive summary:

The test article was administered as supplied, without rinsing and at the dose level of 52 mg (quantity corresponding to a volume of 0,1 ml) per animal, into the inferior conjunctival sac of the right eye of 6 New-Zealand hybrid albino male rabbits. The ocular examinations were performed in the conjunctiva, iris and cornea, according to a given numerical scale, 1 hour after administration of the test article, then at 24, 48 and 72 hours. Mean values were calculated from the quantitative and qualitative evaluation of ocular lesions performed in all the rabbits examined at 24, 48 and 72 hours. The average irritation scores recorded (24h ,48h ,72h) were 0.22 for chemosis, 0.67 for erythema, 0.44 for iris and 0.0 for cornea. In conclusion, from the results obtained under the experimental conditions, administration of this test article into the rabbit's eye can be designated as NON-IRRITANT.