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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
toxicity to reproduction
Data waiving:
exposure considerations
Justification for data waiving:
other:

Data source

Materials and methods

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

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In view of no data being presented in the 28 day oral toxicity study that indicated effects to the reproductive organs and there being no similarity with known reproductive toxcins, it is not considered justified to perform a new animal test.
Executive summary:

There is predicted to be low exposure to workers under controlled workplace conditions and no exposure to the general public. EUSES modelling with ConsExpo suggests a low risk of accumulation in food and drinking water.

The absence of relevant systemic effects in the 28 day oral study and the low exposure would suggest it is inappropariate to perform further animal studies to meet this end point. If the tonnage exceeds 100 t per annum or if use types change that could lead to increased human exposure, testing may be necessary.