Registration Dossier
Registration Dossier
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EC number: 942-732-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- genetic toxicity in vitro
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- other: expert assessment
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in bacteria.
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in bacteria.
- GLP compliance:
- no
- Type of assay:
- other: An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in bacteria.
- Key result
- Genotoxicity:
- negative
- Remarks on result:
- other: assessment conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in bacteria
- Conclusions:
- Interpretation of results (migrated information):negativeBased on an examination of the capacity of its constituents to induce gene mutation in bacteria, it is concluded that the registered substance is not expected to induce gene mutation in mammalian cells. The registered substance does not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
The potential of reaction mass of 2-aminoethanol and 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, compound with 2-aminoethanol (1:1) to induce gene mutation in bacteria is expected to be driven by the capacity of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, 2-aminoethanol, and water – to induce gene mutation in bacteria.
A GLP study has been performed on 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid according to OECD Guideline 471 and concluded that the substance is negative for gene mutation in bacteria with and without metabolic activation.
The QSAR predictions performed on 2-aminoethanol demonstrated that the substance is not expected to induce gene mutation in bacteria. This conclusion supports a non-GLP study conducted in 1984 by Mortelmans et al. using a method equivalent to OECD Guideline 471, which found 2-aminoethanol to be negative for gene mutation in bacteria with and without metabolic activation.
Based on the activity of its constituents, it is concluded that reaction mass of 2-aminoethanol and 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, compound with 2-aminoethanol (1:1) is not expected to induce gene mutation in bacteria. No further testing is considered as required.
Maron D (1983) Revised Methods for the Salmonella Mutagenicity Test. Mutation Res., 113, 173-215.
Mortelmans K (1986) Salmonella Mutagenicity Tests: II. Results From the Testing of 270 Chemicals. Journal of the Environmental Society 8 (Suppl. S7): 56–119
Reference
An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in bacteria.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The potential of the registered substance to induce gene mutation in bacteria is expected to be driven by the capacity of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, 2-aminoethanol, and water – to induce gene mutation in bacteria.
A GLP study has been performed on 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid according to OECD Guideline 471 and concluded that the substance does not show gene mutation in bacteria with and without metabolic activation.
The QSAR predictions performed on 2-aminoethanol demonstrated that the substance is not expected to induce gene mutation in bacteria. This conclusion supports a study conducted in 1984, which found 2-aminoethanol to be negative for gene mutation in bacteria with and without metabolic activation.
Based on the activity of its constituents, it is concluded that the registered substance is not expected to induce gene mutation in bacteria. No further testing is considered as required.
The potential of the registered substance to induce structural chromosomal aberration in mammalian cells is expected to be driven by the capacity of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, 2-aminoethanol, and water – to induce structural chromosomal aberration in mammalian cells.
A GLP study has been performed on 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid according to OECD Guideline 487 and concluded that the substance is negative for structural chromosomal aberration in mammalian cells with and without metabolic activation.
The QSAR predictions performed on 2-aminoethanol demonstrated that the substance is not expected to induce structural chromosomal aberration in mammalian cells. This conclusion supports a study conducted in 1985, which found 2-aminoethanol to be negative for structural chromosomal aberration in mammalian cells without metabolic activation; this lack of metabolic activation is not considered as significant as the metabolism route of 2-aminoethanol is well-known and the substance is expected to be fully metabolised with NH3 and acetyl-CoA as its final degradation products.
Based on the activity of its constituents, it is concluded that the registered substance is not expected to induce structural chromosomal aberration in mammalian cells. No further testing is considered as required.
The potential of the registered substance to induce gene mutation in mammalian cells is expected to be driven by the capacity of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, 2-aminoethanol, and water – to induce gene mutation in mammalian cells.
A GLP study has been performed on 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid according to OECD Guideline 476 and concluded that the substance is negative for gene mutation in mammalian cells with and without metabolic activation.
The QSAR predictions performed on 2-aminoethanol demonstrated that the substance is not expected to induce gene mutation in mammalian cells. This conclusion supports a study conducted in 1984, which found 2-aminoethanol to be negative for gene mutation in mammalian cells without metabolic activation; this lack of metabolic activation is not considered as significant as the metabolism route of 2-aminoethanol is well-known and the substance is expected to be fully metabolised with NH3 and acetyl-CoA as its final degradation products.
Based on the activity of its constituents, it is concluded that the registered substance is not expected to induce gene mutation in mammalian cells. No further testing is considered as required.
Justification for selection of genetic toxicity endpoint
This study was selected as the key study as it is considered as reliable and representative for this endpoint.
Justification for classification or non-classification
The assessments of the potential of the constituents of Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1) - namely 2-aminoethanol, 6-[(p-tosyl)amino]hexanoic acid, and water - to induce gene mutation in bacteria and in mammalian cells, and structural chromosomal aberration in mammalian cells were negative. As the genotoxic potential of the registered substance is expected to be driven by the genotoxic potential of its constituents, it was concluded that the Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1) is not expected to be genotoxic. There, the registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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