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EC number: 479-410-0 | CAS number: -
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Standard method equivalent to EC method, GLP-compliant, adequate experimental details for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- GLP-compliant test, believed to be broadly comparable to the
old version of EC B5. In 3 additional rabbits, eyes were
flushed with water 20-30 secs after treatement. Irritation
was scored at 1, 24, 72 and 96h and 7 days. Scores were
combined using the Draize system. - GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- Nature of substance: Undiluted liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- test material in instilled in eye for 20-30 seconds then flushed with water
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 2 days
- Other effects:
- No corneal or iridial irritation was seen and there was no
initial pain response. At 24h minor irritation (mean score
0) was seen in unwashed eyes: this had gone by 48h.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study on the analogous substance, Renewable Diesel is expected to be slightly irritating to skin.
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