Registration Dossier
Registration Dossier
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EC number: 700-713-3 | CAS number: 83161-22-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Standard protocole n°CEPC.B.ETU.PRO.RRN.04
In vitro irritation test on fibroblasts of rabbit cornea by neutral red release method - GLP compliance:
- not specified
Test material
- Reference substance name:
- (2S,3R,4R,5R,6R)-2-methyl-6-(pentyloxy)oxane-3,4,5-triol
- EC Number:
- 700-713-3
- Cas Number:
- 83161-22-2
- Molecular formula:
- C11H22O5
- IUPAC Name:
- (2S,3R,4R,5R,6R)-2-methyl-6-(pentyloxy)oxane-3,4,5-triol
- Details on test material:
- For technical reason (solubility), APRC5 was diluted at 30% in a water/glycerol (1/5) mixture
This mixture corresponds to the industrial form.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- in vitro culture of fibrobalsts of rabbit cornea
Test system
- Vehicle:
- other: water/glycerol mixture
- Amount / concentration applied:
- tested dilution : 25, 30 and 35%
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In vitro parameter (RRN)
- Remarks on result:
- other: moderate cytotoxicity
- Irritant / corrosive response data:
- moderate cytotoxicity
Any other information on results incl. tables
| tested dilution | 25% | 30% | 35% |
| cellular mortality % | 7.75 | 17.78 | 48.79 |
| CL50 % | 35.15 | ||
| Classification | moderate toxicity | ||
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- APRC5 is moderately irritating at the concentration tested (i.e. about 10% of pure substance).
In regard to these results, APRC5 substance is considered as irritating.
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