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Diss Factsheets

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:
2004

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

Constituent 1
Chemical structure
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.

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.