Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin 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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Remarks:
Original 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

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
water
Amount / concentration applied:
500mg
Duration of treatment / exposure:
4 Hours.
Observation period:
72 Hours after administration.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The material is not a skin irritant.
Executive summary:

The material is not a skin irritant.