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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Oct to Nov 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]-1H-isoindole-1,3(2H)-dione
EC Number:
610-200-5
Cas Number:
446292-07-5
Molecular formula:
C21 H21 N3 O5
IUPAC Name:
2-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]-1H-isoindole-1,3(2H)-dione
Details on test material:
Hydroxyaminophthalimid, white powder, batch number BXR3528, content 98.2%

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):
72 hours
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:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
There were no systemic intolerance reactions.

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  0.0
   Iritis  0  0  0  0.0
   Redness conjunctivae  0  0  0  0.0
   Chemosis conjunctivae  0  0  0  0.0
 2   Corneal Opacity  0  0  0  0.0
    Iritis  0  0  0  0.0
    Redness conjunctivae  2  1  0  1.0
    Chemosis conjunctivae  0  0  0  0.0
 3   Corneal Opacity  0  0  0  0.0
    Iritis  0  0  0  0.0
    Redness conjunctivae  2  0  0  0.7
    Chemosis conjunctivae  0  0  0  0.0

All animals showed reddening of the conjunctivae 1 h after administration, one animal additionally showed slight chemosis.

Applicant's summary and conclusion

Executive summary:

0.1 g 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 Hydroxyaminophthalimid is not irritating to eyes.