Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol
EC Number:
606-239-2
Cas Number:
19130-96-2
Molecular formula:
C6 H13 N O4
IUPAC Name:
(2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol
Details on test material:
Desoxynojirimycin, solid white to beige powder, content 97.2%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Results of the study

      Irritant Effects (Score)         
 Animal    24 h 48 h   72 h  Mean scores
 1  Corneal Opacity  0 0.0
   Iritis  0  0  0  0.0
   Redness conjunctivae  0  0  0  0.0
   Chemosis conjunctivae  0  0  0  0.0
  Fluorescein  negative  negative  negative
 2  Corneal Opacity  0 0.0 
 Iritis 0.0 
   Redness conjunctivae  0  0  0  0.0
   Chemosis conjunctivae  0  0  0  0.0
   Fluorescein  negative negative  negative   
 3  Corneal Opacity  0  0  0.0
   Iritis  0  0.0
   Redness conjunctivae   0  0  0  0.0
   Chemosis conjunctivae   0  0  0  0.0
   Fluorescein  negative negative  negative   

Applicant's summary and conclusion

Executive summary:

80 mg of the test substance was administered into the conjunctival sac of in each case one rabbit eye of 3 females and after 24 h the treated eyes were rinsed with physiologic saline.

Evaluation of eye irritation was made according to Draize.

According to the classification criteria Desoxynojirimycin is not irritating to eyes.