Registration Dossier
Registration Dossier
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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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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