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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye 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 completed to guideline 84/449/EWG,B.5 GLP Compliance

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not applicable
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 / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 38mgs
- 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:
24 hrs
Observation period (in vivo):
24,48,72 hrs
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritant / corrosive response data:
not classified

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is non irritant and non corrosive
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.