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EC number: 262-996-5 | CAS number: 61788-67-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Good study, no GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 67/548/CEE
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Castor oil, sulfated, sodium salt
- EC Number:
- 269-123-7
- EC Name:
- Castor oil, sulfated, sodium salt
- Cas Number:
- 68187-76-8
- IUPAC Name:
- Castor oil, sulfated, sodium salt
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Castor oil, sulfated, sodium salt
- Molecular formula: no data
- Molecular weight : no data
- Smiles notation: no data
- InChl: no data
- Substance type: no data
- Physical state:li quid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: breeding center Padre Antonio
- Weight at study initiation:2 - 3 kg
- Housing: stainless steel cage 1472 Tecniplast with autowashing (10 sec. every hour)
- Diet: full pellet, ad libitum.
- Water: municipal water filtered with Seitz filter, ad libitum.
- Acclimation period: 7 days
- Healt check: 24 hours before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 55±15
- Air changes (per hr):8
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml/animale - Duration of treatment / exposure:
- one injection
- Observation period (in vivo):
- 1, 24, 48, 72
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: according to DAIZE test
TOOL USED TO ASSESS SCORE: fluorescein, and UV lamp (365 nm)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0.33
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- ca. 0.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: conjunctive congestion score
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: conjunctive congestion score
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- ca. 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: conjunctiva chemosis
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: conjunctiva chemosis
Any other information on results incl. tables
| tissue | observation period | rabbit | Mean | |||||
| 1 | 2 | 3 | 4 | 5 | 6 | |||
| Cornea | 1h | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
| 24h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
| 48h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
| 72h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
| 7days | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
| Iris | 1h | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
| 24h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| 48h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| 72h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| 7days | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| Conjunctiva | 1h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 |
| 24h | 3 | 3 | 3 | 2 | 2 | 2 | 2.50 | |
| 48h | 3 | 2 | 2 | 2 | 2 | 2 | 2.16 | |
| 72h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 | |
| 7days | 1 | 1 | 1 | 1 | 1 | 1 | 1.00 | |
| chemosis | 1h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 |
| 24h | 3 | 2 | 2 | 3 | 3 | 3 | 2.83 | |
| 48h | 3 | 2 | 2 | 2 | 2 | 3 | 2.33 | |
| 72h | 2 | 2 | 1 | 1 | 1 | 2 | 1.50 | |
| 7days | 1 | 0 | 1 | 1 | 0 | 1 | 0.66 | |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on results castrol oil is considered irritant for rabbit eyes.
- Executive summary:
Castrol oil is tested on albino rabbit's eyes by DRAIZE test (67/548/ECC method). Based on results after 7 days of observation , castrol oil is considered irritant for rabbit eyes.
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