Registration Dossier
Registration Dossier
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EC number: 298-364-0 | CAS number: 93803-89-5
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:
- weight of evidence
- Study period:
- 23. Dec. 1989 - 01. Jan. 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles (no data on test substance purity).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no data on test substance purity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm Laboratories Limited, Derby, UK
Test material
- Reference substance name:
- 131459-39-7
- Cas Number:
- 131459-39-7
- IUPAC Name:
- 131459-39-7
- Details on test material:
- - Physical state: straw colored liquid
- Analytical purity: not given, responsibility of the sponsor
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 3.12 - 3.29 kg
- Housing: individual housing in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 19
- Humidity (%): 43 - 64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 72 hours
reading time points: 1, 24, 48, 72 hours - Number of animals or in vitro replicates:
- 2 male and 1 female
- Details on study design:
- SCORING SYSTEM: Draize Scoring System
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (out of all 3 animals)
- Time point:
- other: mean over 24 m 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (out of all 3 animals)
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2 and animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No corneal or irridal effects were noted. Moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal conjunctival irritation noted in all treated eyes at the 24-hour observation and one treated eye at the 48-hour observation. Treated eyes appeared normal 48 to 72 hours after treatment.
Any other information on results incl. tables
| Table 1: Results of eye irritation study. | ||||||||||
| Rabbit # | Time [h] | conjunctivae | iris | cornea | conjunctivae | iris | cornea | |||
| redness | swelling | redness | swelling | |||||||
| 1 | 1 | 2 | 1 | 0 | 0 | |||||
| 24 | 1 | 1 | 0 | 0 | ||||||
| 48 | 1 | 1 | 0 | 0 | ||||||
| 72 | 0 | 0 | 0 | 0 | ||||||
| average | 0,7 | 0,7 | 0,0 | 0,0 | Time to reversion (h) | 72,0 | 72,0 | 0,0 | 0,0 | |
| 2 | 1 | 2 | 2 | 0 | 0 | |||||
| 24 | 1 | 1 | 0 | 0 | ||||||
| 48 | 0 | 0 | 0 | 0 | ||||||
| 72 | 0 | 0 | 0 | 0 | ||||||
| average | 0,3 | 0,3 | 0,0 | 0,0 | Time to reversion (h) | 48,0 | 48,0 | 0,0 | 0,0 | |
| 3 | 1 | 2 | 1 | 0 | 0 | |||||
| 24 | 1 | 0 | 0 | 0 | ||||||
| 48 | 0 | 0 | 0 | 0 | ||||||
| 72 | 0 | 0 | 0 | 0 | ||||||
| average | 0,3 | 0,0 | 0,0 | 0,0 | Time to reversion (h) | 48,0 | 0,0 | 0,0 | 0,0 | |
| Time [h] | conjunctivae | iris | cornea | |||||||
| redness | swelling | avg. time to reversion | 56,0 | 40,0 | 0,0 | 0,0 | ||||
| average score |
1 | 2,00 | 1,33 | 0,00 | 0,00 | |||||
| 24 | 1,00 | 0,67 | 0,00 | 0,00 | ||||||
| 48 | 0,33 | 0,33 | 0,00 | 0,00 | ||||||
| 72 | 0,00 | 0,00 | 0,00 | 0,00 | ||||||
| 24+48+72 | 0,44 | 0,33 | 0,00 | 0,00 | ||||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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