Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 942-732-1 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- 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.
Data source
Reference
- Reference Type:
- other: expert assessment
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- EC Number:
- 942-732-1
- Molecular formula:
- C13H19NO4S.C2H7NO/C2H7NO/H2O
- IUPAC Name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- Reference substance name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- IUPAC Name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- Test material form:
- other: liquid
- Details on test material:
- Name of test material: Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)Physical state: pale yellow liquidSubstance type: multi-constituent substance
Constituent 1
Constituent 2
Results and discussion
Test results
- 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
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
