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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 265-019-0 | CAS number: 64690-19-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-octylpyridin-4-amine
- EC Number:
- 265-019-0
- EC Name:
- N-octylpyridin-4-amine
- Cas Number:
- 64690-19-3
- Molecular formula:
- C13H22N2
- IUPAC Name:
- N-octylpyridin-4-amine
Constituent 1
- Specific details on test material used for the study:
- Characterisation of the Test Item
The test item and the information concerning the test item were provided by the sponsor. All data related to the test item are the responsibility of the sponsor and have not been verified by the test facility.
Name: N-Octyl-4-pyridinamine
Batch No.: 565-083
Molecular Weight:206.33 g/mol
Purity: 100%
Physical State/ Colour: solid / white
Storage Conditions: room temperature
Expiry Date: 09 July 2014
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Experiment I:
0.316, 1.00, 3.16, 10.0, 31.6, 100, 316 and 1000 µg/plate
(for tester strains TA 100, TA 1535, TA 1537 and TA 102)
3.16, 10.0, 31.6, 100,316 and 1000 µg/plate
(only for tester strain TA 98)
Experiment II:
1.58, 5.00, 15.8, 50.0, 158, 500 and 1000 µg/plate - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, 4-nitro-o-phenylene-diamine
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Discussion
The test item N-Octyl-4-pyridinamine was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I and II) using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments:
Experiment I:
0.316, 1.00, 3.16, 10.0, 31.6, 100, 316 and 1000 µg/plate
(for tester strains TA 100, TA 1535, TA 1537 and TA 102)
3.16, 10.0, 31.6, 100, 316 and 1000 µg/plate
(only for tester strain TA 98)
Experiment II:
1.58, 5.00, 15.8, 50.0, 158, 500 and 1000 µg/plate
No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation) .
Toxic effects of the test item were noted in all tester strains evaluated in experiment I and II.
In experiment I toxic effects of the test item were observed in tester strain TA 98 at concentrations of 316 µg/plate and higher (with and without metabolic activation) . In tester strain TA 100 toxic effects of the test item were noted at concentrations of
31.6 µg/plate and higher (without metabolic activation) and at concentrations of 100 µg/plate and higher (with metabolic activation). In tester strains TA 1535 and TA 1537 toxic effects of the test item were observed at concentrations of 31.6 µg/plate and higher (without metabolic activation) and at concentrations of 316 µg/plate and higher (with metabolic activation). In tester strain TA 102 toxic effects of the test item were noted at concentrations of 100 µg/plate and higher (without metabolic activation) and at concentrations of 316 µg/plate and higher (with metabolic activation).
In experiment II toxic effects of the test item were noted in all tester strains at concentrations of 158 µg/plate and higher (without metabolic activation) and at concentrations of 500 µg/plate and higher (with metabolic activation).
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with N-Octyl-4-pyridinamine at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, N-Octyl-4-pyridinamine did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, N-Octyl-4-pyridinamine is considered to be non-mutagenic in this bacterial reverse mutation assay.
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.
