1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Remarks:

QAU statement available

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

EC Number:

248-597-9

EC Name:

1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Cas Number:

27676-62-6

Molecular formula:

C48H69N3O6

IUPAC Name:

1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Details on test material:

- Physical state: solid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2050 to 2170 g
- Housing: individually
- Diet: Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

not specified

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 females

Details on study design:

0.1 ml of the test substance was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the
instillation.

SCORING SYSTEM: OECD scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0.56

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Irritant / corrosive response data:

The test substance caused mild, early-onset and transient reddening of the conjunctivae, chemosis and effects to the iris. All observed effects were reversible within 7 days the latest (for details see table).

Any other information on results incl. tables

Individual reactions:

	cornea	iris	conjunctival redness	chemosis
Animal #1 (F)
1 hrs	0	1	2	1
24 hrs	0	0	1	0
48 hrs	0	0	0	0
72 hrs	0	0	0	0
7 days	0	0	0	0
Animal #2 (F)
1 hrs	0	1	2	1
24 hrs	0	0	1	0
48 hrs	0	0	0	0
72 hrs	0	0	0	0
7 days	0	0	0	0
Animal #3 (F)
1 hrs	0	1	2	1
24 hrs	0	0	1	0
48 hrs	0	0	1	0
72 hrs	0	0	1	0
7 days	0	0	0	0

Body weights

Animal No.	1	2	3
at start of test	2120	2050	2170
after 3 days	2170	2110	2140
sfter 7 days	2310	2260	2310

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

The test item is considered to be "not irritating" to the rabbit eye.

Executive summary:

The primary eye irritation potential of the test substance was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The instillation of the test substance into the eye resulted in mild, early-onset and transient reddening of the conjunctivae, chemosis and effects to the iris. All observed effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea of any animal at any of the examinations. A slight loss of weight was observed in animal No. 3 on day 3.

In conclusion, the test item did not induce significant or irreversible damage to the rabbit eye and is considered to be "not irritating" to the rabbit eye.