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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

An assessment was performed based on available data on the individual constituents of the substance. It was concluded that N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to be mutagenic.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
other: expert assessment
Adequacy of study:
weight of evidence
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was performed based on available data on the individual constituents of the substance
Qualifier:
no guideline required
Principles of method if other than guideline:
An assessment was performed based on available data on the individual constituents of the substance
GLP compliance:
no
Type of assay:
in vitro mammalian chromosome aberration test
Remarks on result:
other: N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce structural chromosomal aberration in mammalian cells.
Conclusions:
N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce structural chromosomal aberration in mammalian cells.
Executive summary:

An assessment was performed based on available data on the individual constituents of the substance. It was concluded that N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce structural chromosomal aberration in mammalian cells.

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
other: expert assessment
Adequacy of study:
weight of evidence
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was performed based on available data on the individual constituents of the substance
Qualifier:
no guideline required
Principles of method if other than guideline:
An assessment was performed based on available data on the individual constituents of the substance
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Remarks on result:
other: N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce gene mutation in bacteria.
Conclusions:
N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce gene mutation in bacteria.
Executive summary:

An assessment was performed based on available data on the individual constituents of the substance. It was concluded that N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce gene mutation in bacteria.

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
other: expert assessment
Adequacy of study:
weight of evidence
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was performed based on available data on the individual constituents of the substance
Qualifier:
no guideline required
Principles of method if other than guideline:
An assessment was performed based on available data on the individual constituents of the substance
GLP compliance:
no
Type of assay:
in vitro mammalian cell gene mutation test using the Hprt and xprt genes
Remarks on result:
other: N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce gene mutation in mammalian cells.
Conclusions:
N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce gene mutation in mammalian cells.
Executive summary:

An assessment was performed based on available data on the individual constituents of the substance. It was concluded that N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) is not expected to induce gene mutation in mammalian cells.

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

Additional information

Justification for classification or non-classification

N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) does not meet the criteria for classification as mutagenic according to Regulation (EC) No.1272/2008.