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EC number: 403-140-4 | CAS number: 103694-68-4 MAJANTOL; MAJANTOL R
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-03-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- please refer to "principles of method if other than guideline"
- Principles of method if other than guideline:
- study period not sufficient to evaluate (ir)revervesibility of observed effects
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(2,2-dimethyl-3-hydroxypropyl)toluene
- EC Number:
- 403-140-4
- EC Name:
- 3-(2,2-dimethyl-3-hydroxypropyl)toluene
- Cas Number:
- 103694-68-4
- Molecular formula:
- C12H18O
- IUPAC Name:
- 2,2-dimethyl-3-(3-methylphenyl)propan-1-ol
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: not specified
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 2 °C
- Humidity: 50 - 85 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- single application, no washing
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not done
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: fluorescein
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:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- 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:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- 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:
- 2
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
Any other information on results incl. tables
Table 1 Individual results
|
Hours after treatment |
||||
1 |
24 |
48 |
72 |
24/48/72 mean |
|
Animal #1 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
1 |
1 |
0 |
0.67 |
Conjunctiva Redness |
2 |
2 |
2 |
2 |
2 |
Chemosis |
2 |
2 |
1 |
1 |
1.33 |
Animal #2 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
1 |
0 |
0 |
0.33 |
Conjunctiva Redness |
2 |
2 |
2 |
1 |
1.67 |
Chemosis |
2 |
2 |
1 |
1 |
1.33 |
Animal #3 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
Conjunctiva Redness |
2 |
2 |
2 |
1 |
1.67 |
Chemosis |
2 |
3 |
2 |
1 |
2 |
Animal #4 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
Conjunctiva Redness |
2 |
2 |
1 |
0 |
1 |
Chemosis |
2 |
2 |
1 |
0 |
1 |
Animal #5 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
1 |
0 |
0 |
0.33 |
Conjunctiva Redness |
2 |
2 |
2 |
1 |
1.67 |
Chemosis |
2 |
2 |
1 |
0 |
1 |
Animal #6 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
1 |
1 |
0 |
0 |
0.33 |
Conjunctiva Redness |
3 |
3 |
2 |
1 |
2 |
Chemosis |
2 |
3 |
2 |
1 |
2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the test item is considered to be not irritating to the rabbits eye.
- Executive summary:
To assess the test item for its eye-irritation properties six New Zealand White rabbits were used. Prior to start of study and both, 24 h and 72 p.a. the eyes were examined for ocular lesions by means of fluorescein and UV-light. All other observations were performed without fluorescein. The test sample induced in the same animals slight iris-irritations and in all animals mainly slight redness and chemosis of the conjunctiva.
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