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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vivo

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Administrative data

in vivo mammalian somatic cell study: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
experimental study planned after acceptance of testing proposal - planned 1-2Q 2023
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Communication that the Comet assay will not be submitted by the deadline set in the FD due to a delay in the sample availability for testing and the slot in the toxicological laboratory. See more detailed information attached.

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Version / remarks:
29 July 2016
GLP compliance:
yes (incl. QA statement)
Type of assay:
mammalian comet assay

Test material

Chemical structure
Reference substance name:
Reaction mass of N-butylphthalimide and N-sec-butylphthalimide and N-propylphthalimide
Molecular formula:
C11 H11 N O2 + C12 H13 N O2
Reaction mass of N-butylphthalimide and N-sec-butylphthalimide and N-propylphthalimide
Test material form:

Results and discussion

Test results
Remarks on result:
other: study on going

Applicant's summary and conclusion