Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: genome mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP complicance, not OECD guideline

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.14
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
426-480-5
EC Name:
-
Cas Number:
63562-33-4
Molecular formula:
C17H15O6P
IUPAC Name:
2-({9-oxo-8-oxa-9λ⁵-phosphatricyclo[8.4.0.0²,⁷]tetradeca-1(10),2,4,6,11,13-hexaen-9-yl}methyl)butanedioic acid

Method

Species / strain
Species / strain / cell type:
other: bacteria, other: sat TA 98, 100, 1535, 1537
Metabolic activation system:
Liver homogenate from rats treated with Aroclor 1254
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 100 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 μg/plate
Vehicle / solvent:
Solvent: DMSO

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Additional information on results:
none
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation