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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study to Guideline 84/449/EWG,B.4 by GLP compliant laboratory

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
EC Number:
404-360-3
EC Name:
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
Cas Number:
119313-12-1
Molecular formula:
C23H30N2O2
IUPAC Name:
2-benzyl-2-(dimethylamino)-1-[4-(morpholin-4-yl)phenyl]butan-1-one

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: moistened with Tween 80
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
4 hrs
Observation period:
24, 48 &72 hrs
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM: Erythem score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48,72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24.48.72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not classified
Executive summary:

Due to the lack of information provided by ECHA, it is difficult to assess this end point fully. It appears from information provided that the substance has low irritation.