Registration Dossier
Registration Dossier
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EC number: 204-614-1 | CAS number: 123-28-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP. Comparable to OECD 405, without recording of body weight and clinical signs.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No indication of the method used to examine ocular reactions. For three of the six rabbits, eyes rinsed after 30 seconds after the test substance application.
- GLP compliance:
- no
Test material
- Reference substance name:
- Dioctadecyl 3,3'-thiodipropionate
- EC Number:
- 211-750-5
- EC Name:
- Dioctadecyl 3,3'-thiodipropionate
- Cas Number:
- 693-36-7
- Molecular formula:
- C42H82O4S
- IUPAC Name:
- dioctadecyl 3,3'-sulfanediyldipropanoate
- Details on test material:
- - Name of test material (as cited in study report): IRGANOX PS 802
- Substance type: Organic
- Physical state: Solid white granules
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred on the premises and maintained under a semi-barrier system
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.41 kg (males); 2.24 kg (females)
- Housing: Individually
- Diet (ad libitum): commercial irradiated diet (Styles-Oxoid)
- Water (ad libitum)
- Acclimation period: 1 w
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 14 / 10
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 3 rabbits: eye lid held close for one second, no further washing
3 rabbits: eye lid held close for one second, then flushing with warm water for one minute - Observation period (in vivo):
- 72 h (examination after 1h, 6h, 48h and 72h)
- Number of animals or in vitro replicates:
- 3 rinsed eyes
3 non-rinsed eyes - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Warm water for 1 m (3 animals out of 6)
- Time after start of exposure: 30 s
SCORING SYSTEM: Draize Score (cornea scores 0 - 4, iris scores 0 - 2, conjunctiva scores 0-4 for chemosis and 0 - 3 for redness and discharge)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6h
- Remarks on result:
- other: no chemosis at later observation time points. Results based on animals with non-rinsed eyes.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 6h and 24h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: No redness observed at later observation time points. Results based on animals with non-rinsed eyes.
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 h
- Remarks on result:
- other: No further discharge observed at later observation time points. Results based on animals with non-rinsed eyes.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Results based on animals with non-rinsed eyes.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Results based on animals with non-rinsed eyes.
- Irritant / corrosive response data:
- No indication of eye corrosion observed.
- Other effects:
- Results are not different if the rinsed eyes are evaluated.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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