Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.