Registration Dossier
Registration Dossier
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EC number: 271-867-2 | CAS number: 68610-51-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-12-1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according OECD Guideline 405 under GLP conditions. No deviations reported, although the identity and quality of the tested substance is not controlled.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- EC Number:
- 271-867-2
- EC Name:
- Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- Cas Number:
- 68610-51-5
- Molecular formula:
- C10H12.C7H8O.C4H8
- IUPAC Name:
- 2-(8-{3-[8-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-4-yl]-2-hydroxy-5-methylphenyl}tricyclo[5.2.1.0²,⁶]decan-4-yl)-6-[4-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]-4-methylphenol
- Details on test material:
- - Name of test material (as cited in study report): Lowinox 22CP46
(Lowinox 22CP46 is a precursor of Lowinox CPL; Lowinox 22CP46 mainly consists of lower MW components of the current Lowinox CPL, which has a wider MW range (information provided by sponsor))
- Substance type: off-white powder
- Physical state: solid
- Analytical purity: not mentioned
- Impurities (identity and concentrations): not mentioned
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: 4671
- Expiration date of the lot/batch: not mentioned
- Stability under test conditions: not mentioned
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Neuendamm 88, Germany
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually in steenless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 -20
- Humidity (%): 50 - 85
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: According to Draize
TOOL USED TO ASSESS SCORE: fluorescein + UV-light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0.25
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- see above table
- Other effects:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A study in 3 rabbits revealed that Lowinox R 22CP46 was not irritanting for the eye. The study was performed according to the general guidelines for acute eye irritation/corrosion under GLP conditions.
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