Registration Dossier
Registration Dossier
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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted May 12, 1981)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,6-bis(octylthiomethyl)-o-cresol
- EC Number:
- 402-860-6
- EC Name:
- 4,6-bis(octylthiomethyl)-o-cresol
- Cas Number:
- 110553-27-0
- Molecular formula:
- C25 H44 O S2
- IUPAC Name:
- 2-methyl-4,6-bis[(octylsulfanyl)methyl]phenol
- Details on test material:
- - Storage: room temperature
- Physical state: liquid
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 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Sex: male
- Weight at study initiation: 2060-2170 g (within ± 20% of mean value)
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum (quality of the drinking water met the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972))
- Acclimation period: 5 days
- Rationale for choice: The albino rabbit is the recommended species for acute eye irritation/corrosion studies
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
The test substance was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second to prevent loss of the test material. - Duration of treatment / exposure:
- eyes were not washed after instillation
- Observation period (in vivo):
- The ocular reactions were evaluated 1, 24, 48, 72 hours and 7 days after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to the OECD scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Two animals showed minimal edema (score 1) one hour after instillation, reversible within 24 hours. All animals had minimal erythema (score 1) during evaluation time points 1h, 24h and 48 h, reversible within 72 hours. No signs of irritation was seen on the iris and cornea.
- Other effects:
- A slight loss of weight was observed in one animal on day 3 (2110 g versus 2130 g at start of test)
Any other information on results incl. tables
Overview of results:
| Animal 1 | Animal 2 | Animal 3 | ||
| redness | 1 h | 1 | 1 | 1 |
| 24 h | 1 | 1 | 1 | |
| 48 h | 1 | 1 | 1 | |
| 72 h | 0 | 0 | 0 | |
| 7 days | 0 | 0 | 0 | |
| chemosis | 1 h | 1 | 0 | 1 |
| 24 h | 0 | 0 | 0 | |
| 48 h | 0 | 0 | 0 | |
| 72 h | 0 | 0 | 0 | |
| 7 days | 0 | 0 | 0 | |
| cornea | 1 h | 0 | 0 | 0 |
| 24 h | 0 | 0 | 0 | |
| 48 h | 0 | 0 | 0 | |
| 72 h | 0 | 0 | 0 | |
| 7 days | 0 | 0 | 0 | |
| Iris | 1 h | 0 | 0 | 0 |
| 24 h | 0 | 0 | 0 | |
| 48 h | 0 | 0 | 0 | |
| 72 h | 0 | 0 | 0 | |
| 7 days | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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