Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.14
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
bacteria, other: sat TA 98, 100, 1535, 1537
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 μg/plate
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
not specified
Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Based on the available information in the dossier, the substance 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one (CAS No. 89331-94-2) does not need to be classified for germ cell mutagenicity when the criteria outlined in CLP Regulation (Annex I of 1272/2008/EC) are applied.