Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Remarks:
QSAR
Justification for type of information:
QSAR The bacterial in vitro genotoxicity QSAR prediction was assessed as adequate for regulatory purposes (Klimisch 2 – results derived from a valid QSAR model and falling into its
applicability domain, with adequate and reliable documentation/justification).

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
QSAR
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Cycloate
IUPAC Name:
Cycloate
Details on test material:
Cycloate

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella
Remarks:
QSAR
Metabolic activation:
not specified
Genotoxicity:
negative
Remarks:
QSAR
Cytotoxicity / choice of top concentrations:
not determined
Remarks:
QSAR
Vehicle controls validity:
not specified
Remarks:
QSAR
Untreated negative controls validity:
not examined
Remarks:
QSAR
Positive controls validity:
not examined

Applicant's summary and conclusion

Conclusions:
Prediction NEGATIVE, based on a positive prediction probability equal to 0.093.
Executive summary:

Ames test prediction for cycloate is NEGATIVE.