Registration Dossier
Registration Dossier
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EC number: 701-246-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Nu-Film-P
- IUPAC Name:
- Nu-Film-P
- Reference substance name:
- Oligomerisation products of beta-pinene
- EC Number:
- 701-246-8
- Molecular formula:
- Variable (dimer = C20-H34)
- IUPAC Name:
- Oligomerisation products of beta-pinene
- Details on test material:
- Typical content of pinene oligomers 96 wt%
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: Ace Animals
- Weight at study initiation: ranged from 2.2 - 2.8 kg
- Housing: Test animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and was changed twice a week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) provided daily.
- Water: ad libitum
- Acclimation period: at least 1 week
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eyes of test animals served as controls
- Amount / concentration applied:
- 0.1 ml of test material
- Duration of treatment / exposure:
- A single treatment followed by observation over 3 days
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6 animals were used in total for this study (5 males; 1 female)
- Details on study design:
- The test substance was introduced into the conjunctival sac after gently pulling the lower eyelid away from the eye. After instillation, the eyelids were held together for 1 second to ensure adequate distribution. The other eye was untreated.
Each treated eye was examined for irritation of the cornea, iris and conjunctiva at 1 hour post instillation and on days 1, 2, and 3. The Draize technique was used to grade ocular reactions. The eyes of all rabbits were examined with sodium fluorescein at 24 hours. In addition the general health of each animals was monitored at each observation time.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- across 6 test animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: All scores zero 1h after treatment
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- across 6 test animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: All scores zero 1h after treatment
- Irritation parameter:
- conjunctivae score
- Remarks:
- (conjunctival redness)
- Basis:
- mean
- Remarks:
- across 6 test animals
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1h post treatment, 4 animals showed score 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- across 6 test animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: All scores zero 1h after treatment
- Irritant / corrosive response data:
- No corneal opacity or iritis were observed during this study. Conjunctival redness and/or discharge were observed in the treated eyes of all rabbits 1h post treatment: after 1 day only a single rabbit showed redness and all appeared normal by Day 2.
- Other effects:
- No abnormal systemic signs were seen during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on EU (DSD and CLP) criteria, the test substance proved non-irritating to eyes in this study
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