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EC number: 500-245-8 | CAS number: 70750-57-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers
- IUPAC Name:
- Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers
- Reference substance name:
- Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers
- EC Number:
- 500-245-8
- EC Name:
- Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers
- Cas Number:
- 70750-57-1
- Molecular formula:
- C10H16 - C50H80
- IUPAC Name:
- Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers. “2,6,6-trimethylbicyclo[3.1.1]hept-2-ene, oligomers, consisting of mainly of dimers and trimers formed from the catalytic partial homo-polymerisation of 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene (also known as alpha-pinene)”,
- Test material form:
- other: clear viscous liquid
- Details on test material:
- - Name of test material (as cited in study report): Zonarez A-25
- Physical state: Clear viscous honey-like liquid
- Analytical purity: Not reported
- Lot/batch No.: AIA804
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc.
- Weight at study initiation: 2-3 kg
- Fasting period before study:
- Housing: Separate isolation by test system
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed.
- Food Analysis: Acute dose minimize the effect of contaminants. There were no contaminants.
- Water (e.g. ad libitum): Fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries Inc.
- Water Analyses: Conducted by Pennsylvania Gas and Water Company
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C+/-3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light-12 hrs dark
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Dose administration: 0.1 ml, undiluted
VEHICLE
- Information not reported - Duration of treatment / exposure:
- Once
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 9 rabbits, 6 treated-no rinsed, 3 treated-rinsed
- Details on study design:
- Methods of the study performance
Twenty-four hrs prior to the application of the test material, the eyes of the rabbit were examined using 2% sodium fluorescein stain. Animals with preexisting corneal injury were removed from the study. The test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of material.
The treated eyes of six rabbits remained unwashed. The treated eyed of three rabbits were rinsed for one minute with lukewarm water immediately following administration of the test material. The contralateral eye remained untreated as served as a control.
The eye were examined at 24, 48, 72 hrs and 4 and 7 days after treatment.
Grading of irritation is according to the method of Draize, J.H, et al., Pharm, Exp. Ther.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Day 4, Day 7
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Day 4, Day 7
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Day 4, Day 7
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- One positive ocular reading was observed at 24 hrs post administration. No other positive responses were observed. One positive response were recorded during the course of the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers was not an eye irritant.
- Executive summary:
The study investigated the capability of Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers to induce eye irritation in 9 New Zealand rabbits. The test material was instilled in the right eye of the rabbits. The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were rinsed for one minute with lukewarm water immediately following administration of the test article. One positive ocular reading was recorded at 24 hrs post administration. Only one positive response was observed during the course of the study. Based upon the observation made in the Primary Eye Irritation test, the test material is not considered an eye irritant.
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