Registration Dossier

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Justification for type of information:
With reference to the evaluation decisions CCH-D-2114511214-66-01/F for the substance with EC number 204-354-9, we were informed by the laboratory that the test of OECD 471 will be postponed to Feb. 26, 2021 and the final report will be rescheduled to Mar. 2021. There will be a slight delay in updating the dossier. The attachment is the deferred document of the laboratory. According to the advice of the communication in INC000000339947 with ECHA, hereby we submit an update of our dossier including this explanation and evidence file concerning the delay. And we will submit the updated dossier with the complete data as soon as the final report is available. It's expected to be completed within two months.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3,4-dihydrocoumarin
EC Number:
204-354-9
EC Name:
3,4-dihydrocoumarin
Cas Number:
119-84-6
Molecular formula:
C9H8O2
IUPAC Name:
3,4-dihydrocoumarin

Results and discussion

Test results
Species / strain:
not specified
Metabolic activation:
not specified
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Waiting for the final report.

Applicant's summary and conclusion