2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 19, 1997 through March 27, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): CF-C-1607
- Physical state: yellow solid
- Analytical purity: >98%
- Lot/batch No.: 003
- Expiration date of the lot/batch: August 31, 1998
- Storage condition of test material: at room temperature (ca. 20°C) away from direct sunlight

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D-88397 BiberachlRiss
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 3059 g; females: 2982 - 3194 g
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no. 75/97).
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum, in water bowls
- Acclimation period: Four days under test conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye used as reference control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per animal

Duration of treatment / exposure:

Test article applied once then animals observed for 72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1 male, 2 females

Details on study design:

SCORING SYSTEM: according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (A. Riegger, Basel/Switzerland)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.44

Max. score:

3

Reversibility:

fully reversible within: 72h

Remarks on result:

other: no score of 2 or greater

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Application of the test article to healthy rabbit conjunctivae resulted in a mean conjunctival redness score of 0.44 (24-72h; all animals). Other scores were unaffected.

Other effects:

No staining of the cornea, sclera or conjunctivae by the test article was observed.

Any other information on results incl. tables

Table 1. Body weight (g) of test animals.

Animal No.	Sex	First Day of Acclimatisation	First Day of Treatment	Last Day of Observation
31	Male	3059	3106	3150
32	Female	2982	3191	3137
33	Female	3194	3422	3613

Table 2. Eye irritation scores - individual values.

Animal No.	Sex	Evaluation interval	Corneal Opacity	Iris	Conjunctivae		Cumulative
					Redness	Chemosis	Score	Mean
31	M	1 hour	0	0	2	1	3.00	3.00
32	F		0	0	2	1	3.00
33	F		0	0	2	1	3.00
31	M	24 hours	0	0	1	0	1.00	1.00
32	F		0	0	1	0	1.00
33	F		0	0	1	0	1.00
31	M	48 hours	0	0	0	0	0.00	0.33
32	F		0	0	0	0	0.00
33	F		0	0	1	0	1.00
31	M	72 hours	0	0	0	0	0.00	0.00
32	F		0	0	0	0	0.00
33	F		0	0	0	0	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: OECD GHS

Conclusions:

Based upon the referred classification criteria, CGF-C-1607 IS considered to be "not irritating" to the rabbit eye.

Executive summary:

The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. Ocular reactions were observed approximately 1 hour, 24, and 48 hours after the administration. Mean scores calculated for all animals over 24, 48 and 72 hours was 0.44 for redness of the conjunctiva. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals. Based upon the referred classification criteria, CGF-C-1607 is considered to be "not irritating" to the eye.