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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
(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).
Qualifier:
no guideline followed
Principles of method if other than guideline:
QSAR
GLP compliance:
no
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
Conclusions:
Prediction NEGATIVE, based on a positive prediction probability equal to 0.093.
Executive summary:

Ames test prediction for cycloate is NEGATIVE.


Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
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
Qualifier:
no guideline followed
Principles of method if other than guideline:
QSAR
GLP compliance:
no
Type of assay:
mammalian erythrocyte micronucleus test
Key result
Sex:
not specified
Genotoxicity:
negative
Remarks:
QSAR
Remarks on result:
not measured/tested
Remarks:
QSAR
Conclusions:
ACD/Percepta genotoxicity (micronucleus in vivo) prediction is NEGATIVE, based on a positive prediction probability equal to 0.154.
In support to the above prediction, it is noted that ACD/Percepta did not identify relevant structural alerts for clastogenicity.
It is highlighted that a negative experimental data on micronucleus in vivo test (mouse/male and female/bone marrow) for the target compound Cycloate is available (CCRIS
Database).
Executive summary:

ACD/Percepta genotoxicity (micronucleus in vivo) prediction is NEGATIVE,

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

EPTC is not classified as germ cell mutagenicity based on in vivo genetic toxicity tests.