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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
6-dimethylamino-3,3-bis(4-dimethylaminophenyl)phthalide
EC Number:
216-293-5
EC Name:
6-dimethylamino-3,3-bis(4-dimethylaminophenyl)phthalide
Cas Number:
1552-42-7
Molecular formula:
C26H29N3O2
IUPAC Name:
6-dimethylamino-3,3-bis(4-dimethylaminophenyl)phthalide
impurity 1
Reference substance name:
dihydrogen oxide
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
dihydrogen oxide
Test material form:
solid: particulate/powder

Method

Species / strainopen allclose all
Species / strain / cell type:
other: S. typhimurium TA 1535, 1537, 97 and 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9

Results and discussion

Test results
Key result
Species / strain:
other: S. Typhimurium TA 97/100/1535/1537; E. Coli WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion