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EC number: 473-310-0 | CAS number: 478385-88-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-09-05 to 2006-11-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 473-310-0
- EC Name:
- -
- Cas Number:
- 478385-88-5
- Molecular formula:
- C18H20
- IUPAC Name:
- 4-methyl-4'-[(3E)-pent-3-en-1-yl]-1,1'-biphenyl
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: about 37 weeks
- Weight at study initiation: 5.62 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 20 °C
- Humidity: 47 - 75 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part.
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not done
SCORING SYSTEM: according to Draize
- Preparation: Before the application, the test material was ground in a mortar using a pestle.
- Administration and dose level: To ensure that only rabbits with normal eyes were included in the study, approximately 24 hours before treatment ophthalmological examinations were performed after instillation of a 0.15 % fluorescein solution (Dr. Thilo & Co.) using an ophthalmoscope according to Eisenhut (Basel). Animals with eye defects, injury or irritation were excluded. 0.1 g test material was instilled into the conjunctival sac of the left eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test material was placed. The right eye remained untreated and served as control. After instillation, the eyelids were closed for about 30 seconds.
- Observation for clinical symptoms
The rabbits were examined for eye irritation and for changes in behavior and general condition 1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part. Eye changes were evaluated according to the DRAIZE- , OECD- and EEC recommendations.
- Body weight
Body weight was recorded on days 1, 5, and 8, of the experimental part.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No signs of irritation were observed at the cornea or iris. One hour after treatment the conjunctivae showed only discharge (score 1). Thereafter no signs of irritation were observed.
The confirmatory test with two further animals showed no signs of irritation at the cornea or iris. One hour and 24 hours after treatment the conjunctivae showed redness (score 1) in two animals. Furthermore discharge (score 1) was seen in both animals one hour after treatment. Thereafter, no signs of irritation were observed. - Other effects:
- - Clinical signs
No signs of clinical toxicity were detected.
- Mortality
All animals survived the observation period.
- Body weight
Body weight development of the treated rabbits was inconspicuous.
Any other information on results incl. tables
Table 1 Individual findings
Animal |
Day |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
No. |
Hour(s) |
|
(1) |
(24) |
(48) |
(72) |
|
|
|
|
1 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
2 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No eye irritating potential could be detected, thus the test material is considered to be not an eye irritant.
- Executive summary:
The purpose of this primary eye irritation assay was to provide information on possible health hazards in case of acute eye contact with a test material and serve as a a rational basis for risk assessment to the eye irritating potential of the test item in man. To test for eye irritation a test according to the OECD-Guidelines for Testing of Chemicals No. 405, the annex to Directive 92/69 EEC, and the recommendations of DRAIZE (1959) was performed. No signs of irritation were observed at the cornea or iris. One hour and 24 hours after treatment, the conjunctivae showed redness (score I) in two animals. Furthermore, discharge (score I) was seen one hour after treatment. Thereafter no signs of irritation were observed. The untreated eyes were unchanged. No eye irritating potential could be detected, thus the test material is considered to not be an eye irritant.
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