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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:
other: GLP 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

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-950-7
EC Name:
-
Cas Number:
187393-00-6
Molecular formula:
C38-H49-N3-O5
IUPAC Name:
5-[(2-ethylhexyl)oxy]-2-(4-{4-[(2-ethylhexyl)oxy]-2-hydroxyphenyl}-6-(4-methoxyphenyl)-1,3,5-triazin-2-yl)phenol
Details on test material:
- Name of test material (as cited in study report): CGF-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: 3106 g; females: 3191 - 3422 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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 - 72 hours
Score:
0.44
Max. score:
4
Remarks on result:
other: no score of 2 or greater
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.44.
Slight to moderate reddening and slight swelling of the conjunctivae were noted in all animals, as well as hyperemia of the scleral blood vessels and slight to moderate watery discharge. All findings were reversible after 48 hours.
No corrosion of the cornea was observed at any of the reading times.
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

Table 3. Eye irritation scores - mean values of 24, 48, and 72 hours.

Animal No.

Sex

Corneal Opacity

N

Iris

N

Conjunctivae

Primary Irritation Score

Redness

N

Chemosis

N

31

M

0.00

3

0.00

3

0.33

3

0.00

3

0.44

32

F

0.00

3

0.00

3

0.33

3

0.00

3

33

F

0.00

3

0.00

3

0.67

3

0.00

3

Table 4. Eye irritation scores - mean values over time.

Evaluation Interval

Corneal Opacity

Iris

Conjunctivae

Redness

Chemosis

1 hour

0.00

0.00

2.00

1.00

24 hours

0.00

0.00

1.00

0.00

48 hours

0.00

0.00

0.33

0.00

72 hours

0.00

0.00

0.00

0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria 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. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. The primary irritation score was 0.44 (max. 13). 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 (EEC Commission Directive 93/211EEC of April 27, 1993), CGF-C-1607 is considered to be "not irritating" to the eye.