Reaction mass of N-butylphthalimide and N-sec-butylphthalimide and N-propylphthalimide

Genetic toxicity: in vivo

Administrative data

Endpoint:

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

Reliability:

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

Reference Type:

study report

Title:

Unnamed

Year:

2023

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material information

1

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

IUPAC Name:

Reaction mass of N-butylphthalimide and N-sec-butylphthalimide and N-propylphthalimide

Test material form:

liquid

Results and discussion

Test results

Remarks on result:

other: study on going