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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
July 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP Guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989
Reference Type:
review article or handbook
Title:
Acute Toxicologic Evaluation of N-Formylaminosorbit
Author:
Bomhard E, Märtins E, Stropp G
Year:
1997
Bibliographic source:
International Journal of Toxicology 16, Suppl. 2, 65, 1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 404
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-deoxy-1-formamido-D-glucitol
EC Number:
618-251-5
Cas Number:
89182-60-5
Molecular formula:
C7 H15 N O6
IUPAC Name:
1-deoxy-1-formamido-D-glucitol
Details on test material:
N-Formylaminosorbit, yellowish powder, batch Ansatz 1/89, purity 96.9%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
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    1 h 24 h   48 h  72 h  7 d   Mean scores
 1 Cornea Opacity 0 0  0  0 0  0.0
  Cornea Area 0 0 0 0 0   
  Fluorescein Intensity - 0 - - -  
  Fluorescein Area - 0 - - -   
  Iris 0 0  0  0  0
  Conjunctivae Redness 0 0  0  0  0  0.0
Conjunctivae Swelling 0  0  0  0  0  0.0
  Aqueous humour 0 0 0 0 0  
  Discharge 1 0 0 0 0  
 2 Cornea Opacity 0  0  0 0  0 0.0 
  Cornea Area 0 0 0 0 0
  Fluorescein Intensity - 0 - - -   
  Fluorescein Area  - 0 - - -   
  Iris  0 0 0 0 0 0.0 
  Conjunctivae Redness 0 0 0 0  0 0.0 
  Conjunctivae Swelling 0 0  0  0  0 0.0 
  Aqueous humour 0 0  0  0  0  
  Discharge 1 0  0  0  0  
 3 Cornea Opacity 0 0  0  0  0 0.0 
  Cornea Area 0 0  0  0  0
  Fluorescein Intensity - 0  -  -  -   
  Fluorescein Area - 0  -  -  -   
  Iris 0 0  0  0  0 0.0 
  Conjunctivae Redness 0 0  0  0  0 0.0 
  Conjunctivae Swelling 0 0  0  0  0 0.0 
  Aqueous humor 0 0  0  0  0  
  Discharge 1 0  0  0  0  

Applicant's summary and conclusion

Executive summary:

100 mg of the test substance was administered into the conjunctival sac of one eye of female rabbits with rinsing 24 h after instillation.

Evaluation of eye irritation was made according to Draize.

According to the classification criteria N-Formylaminosorbit is not irritating to eyes.