Registration Dossier
Registration Dossier
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EC number: 404-800-4 | CAS number: 118832-72-7 IRGANOX L 118
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
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:
- Iso(C10-C14)alkyl (3,5-di-tert-butyl-4-hydroxyphenyl)methylthioacetate
- EC Number:
- 404-800-4
- EC Name:
- Iso(C10-C14)alkyl (3,5-di-tert-butyl-4-hydroxyphenyl)methylthioacetate
- Cas Number:
- 118832-72-7
- Molecular formula:
- C30H52O3S
- IUPAC Name:
- 11-methyldodecyl 2-{[(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]sulfanyl}acetate
- Details on test material:
- - Physical state: liquid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2330 to 2430g
- Housing: Individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3°C
- Humidity: 30-70%
- Photoperiod: 12 hrs light cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1mL of the test substance - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 1, 24, 48, 72 hrs
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- SCORING SYSTEM: OECD scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Mild conjunctival redness and chemosis were observed in all three animals. These effects reverted back to normal within 48 hours. No other signs of irritation were reported.
- Other effects:
- A slight loss of weight was observed in animal on day 3 (considered not to be treatment - related).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not irritating to the rabbit eye under the conditions of this study.
- Executive summary:
An acute eye irritation/corrosion study in New Zealand white rabbits was performed to determine the irritant or corrosive potency of the test item (described in section 1.2). The test was based on the OECD Guideline No. 405 (Acute Eye Irritation/ Corrosion) and was performed on 3 male rabbits, checked for normal eye conditions. 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The lids were then held together for about one second in order to prevent loss of the test article. The animals were checked daily for systemic symptoms and mortality. A slit-lamp was used to facilitate the evaluation. The mean values of the Draize scores at 24, 48 and 72 hrs after application were 1/0/0 for redness and 0/0/0 for chemosis of the conjunctiva. No effects were seen on the opacity of the cornea and on the iris. The test item was no eye irritant under the conditions of this study.
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