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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 FEBRUARY 1986 to 13 JUNE 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was carried out according to GLP guidelines and an international testing protocol (OECD 405). Furthermore, the study was assessed in the current risk assessment report under the excisting substance regulation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No observation at 1 hr and no wash at 24 hr
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 80-004-003
- Physical state: Clear viscous liquid
- Other: The substance was assigned C.S.E. compound number 4450-137.

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino, new zealand
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3.5 kg
- Housing: housed singly under standard laboratory conditions
- Diet: 100 grams of purina rabbit chow supplemented by whole oats daily.
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Other: no extraneous material, such as sawdust or woodchips was used in the cages. The suspended pans beneath the cages were littered with preprepared bedding (easi litter).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
7 days
Observation period (in vivo):
At 24, 48, 72 hrs and at 4 and 7 days. The results were re-evaluated on day 10.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was not done.
- Time after start of exposure: Washing was not done.

SCORING SYSTEM: According to the method of Draize.

TOOL USED TO ASSESS SCORE: a hand held ophtalmoscope and fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: mean ocular irritation score
Basis:
mean
Time point:
other: 24 hrs
Score:
ca. 3.5
Max. score:
19
Reversibility:
not specified
Irritation parameter:
other: mean ocular irritation score
Basis:
mean
Time point:
other: 48 hrs
Score:
ca. 1.17
Max. score:
5
Reversibility:
not specified
Irritation parameter:
other: mean ocular irritation score
Basis:
mean
Time point:
other: 72 hrs, 4 and 7 days
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Irritant / corrosive response data:
One rabbit had a small central opacity (score 2) at 24 hr, which was fainter at 48 hr and cleared at 72 hr. The same animal showed also score 1 for effect on the iris at 24 hr only and slight conjunctival redness and discharge (both score 1) at 24 hr only. Another animal had slight redness of the conjunctivae (score 1) at 24 and 48 hr but no effects at later times. Primary eye irritation score at 24, 48, and 72 hr was 3.5, 1.17 and 0 (average of three time points was 1.6).

Any other information on results incl. tables

Table 1: Score charts primary eye irritation.

24 hrs
Animal # A-1125 A-1108 A-1109 A-1110 A-1111 A-1112
Cornea
A) Opacity 2 0 0 0 0 0
B) Area 1 0 0 0 0 0
Iris 1 0 0 0 0 0
Conjunctivae
A) redness 1 0 0 0 1 0
B) Chemosis 0 0 0 0 0 0
C) Discharge 1 0 0 0 0 0
Control 0 0 0 0 0 0
Weighted score 19 0 0 0 2 0
Total 21
Primary ocular irritation score 3.5
48 hrs
Animal # A-1125 A-1108 A-1109 A-1110 A-1111 A-1112
Cornea
A) Opacity 1 0 0 0 0 0
B) Area 1 0 0 0 0 0
Iris 0 0 0 0 0 0
Conjunctivae
A) redness 0 0 0 0 0 0
B) Chemosis 0 0 0 0 0 0
C) Discharge 0 0 0 0 0 0
Control 0 0 0 0 0 0
Weighted score 5 0 0 0 2 0
Total 7
Primary ocular irritation score 1.17
72 hrs, 4 and 7 days
Animal # A-1125 A-1108 A-1109 A-1110 A-1111 A-1112
Cornea
A) Opacity 0 0 0 0 0 0
B) Area 0 0 0 0 0 0
Iris 0 0 0 0 0 0
Conjunctivae
A) redness 0 0 0 0 0 0
B) Chemosis 0 0 0 0 0 0
C) Discharge 0 0 0 0 0 0
Control 0 0 0 0 0 0
Weighted score 0 0 0 0 0 0
Total 0
Primary ocular irritation score 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Based on the irritation scores the test material is considered as practically nonirritating to the eye.
Executive summary:

Galaxolide (65% HHCB in DEP) was tested in the eyes of 6 rabbits by a procedure essentially equivalent to OECD 405 (no observation at 1 hr and no wash at 24 hr). 0.1 ml of Galaxolide was instilled into the right eye (the left serving as control) of healthy young adult albino rabbits. Both eyes were scored according to the method of Draize at 24, 48, 72, 96 and 168 hr. Four rabbits had no ocular changes at any time. One had a small central opacity (score 2) at 24 hr, which was fainter at 48 hr and cleared at 72 hr. The same animal showed also score 1 for effect on the iris at 24 hr only and slight conjunctival redness and discharge (both score 1) at 24 hr only. Another animal had slight redness of the conjunctivae (score 1) at 24 and 48 hr but no effects at later times. Primary eye irritation score at 24, 48, and 72 hr was 3.5, 1.17 and 0 (average of three time points was 1.6). Based on the irritation scores the test material (Galaxolide) is considered as practically nonirritating to the eye.