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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Described in SNIF 05-04-1850-00 lead notification under NONS. Original reports not read.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Remarks:
Origional report not seen

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
454-720-9
EC Name:
-
Cas Number:
161596-47-0
Molecular formula:
C11 H9 N O3
IUPAC Name:
2-{[(2R)-oxiran-2-yl]methyl}-2,3-dihydro-1H-isoindole-1,3-dione

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
100mg
Observation period (in vivo):
Animals were observed for ocular reactions for 72 hours following administration.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 72 hours
Score:
ca. 0.3
Max. score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 72 hours
Score:
ca. 1
Max. score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 72 hours
Score:
ca. 0.3
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 72 hours
Score:
ca. 1.7
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 72 hours
Score:
ca. 3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 72 hours
Score:
ca. 2.7
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 72 hours
Score:
ca. 2.7
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 72 hours
Score:
ca. 3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 72 hours
Score:
ca. 3
Max. score:
3

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The material is an eye irritant.
Executive summary:

The material is an eye irritant.