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EC number: 228-846-8 | CAS number: 6362-80-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP and guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene
- EC Number:
- 228-846-8
- EC Name:
- 1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene
- Cas Number:
- 6362-80-7
- Molecular formula:
- C18H20
- IUPAC Name:
- (4-methyl-4-phenylpent-1-en-2-yl)benzene
- Details on test material:
- - Physical state: Liquid
- Analytical purity: 2,4-dIphenyl-4-methyl-1-pentene 92% min; 2,4-dIphenyl-4-methyl-2-pentene 5% max
- Lot/batch No.: 1102
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits Ltd., Crawley Down, Sussex, England
- Age at study initiation: Approximately 12 to 14 weeks
- Weight at study initiation: 2.8 to 3.3 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70 %
- Air changes: Approximately 19 per hr
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24 hour period
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- SIngle application.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Grading and scoring of the ocular lesions were performed using the prescribed numerical scoring system as follows
Opacity: degree of density (area most dense taken for reading)
Cornea
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other
than slight dulling of normal lustre),
details of iris clearly visible 1
Easily discernible translucent areas, details
of iris slightly obscured 2
Nacrous areas, no details of iris visible,
size of pupil barely discernible 3
Opaque cornea, iris not discernible through
the opacity 4
Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling,
moderate circumcorneal hyperaemia or
injection, any of these or combination of
any thereof, iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross
destruction (any or all of these) 2
Conjunctivae
Redness (refers to palpebral and bulbar
Conjunctivae excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic
(injected) 1
Diffuse, crimson colour, individual vessels
not easily discernible 2
Diffuse beefy red 3
Chemosis (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating
membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
TOOL USED TO ASSESS SCORE: hand-slit lamp
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
- Reversibility:
- other: no effects seen
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects seen
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects seen
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects seen
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects seen
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects seen
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritant / corrosive response data:
- The numerical scores awarded to the ocular reactions elicited by the test substance are given in Table 1.
No corneal damage or iridial inflammation was seen throughout the observation period.
A diffuse crimson-red colouration of the conjunctivae was seen in two animals at the one hour reading only.
All conjunctival responses had resolved two or three days after instillation
Any other information on results incl. tables
Table 1: Ocular reactions elicited by the test substance
Rabbit number and sex |
Region of Eye |
One hour |
Day after instillation |
|||||
1 |
2 |
3 |
4 |
7 |
||||
845♀ |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
2 |
1 |
0 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
0 |
0 |
0 |
0 |
||
857♀ |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
||
858♀ |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjuctiva |
Redness |
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating to eyes according to the criteria set out in CLP Regulation (EC) no. 1272/2008
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