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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 683-326-1 | CAS number: 68815-17-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tall oil, polymd., oxidized
- EC Number:
- 683-326-1
- Cas Number:
- 68815-17-8
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Tall oil, polymd., oxidized
- Test material form:
- liquid
1
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 Mix
- Test concentrations with justification for top dose:
- The toxicity of the test item was determined with tester strains TA 98 and TA 100 in a preexperiment.
Eight concentrations were tested for toxicity and induction of mutations with three plates each. The experimental conditions in this pre-experiment were the same as described below for the main experiment I (plate incorporation test).
Toxicity may be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control.
The test item was tested in the pre-experiment with the following concentrations:
3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment. 2500 μg/plate was selected as the maximum concentration. - Vehicle / solvent:
- The test item was dissolved in THF and diluted prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Remarks:
- A. dest., Eurofins Munich, Lot No. 170220
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tetrahydrofuran (THF), AppliChem Lot No. 1K005341; Merck Lot No. 1864407
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene; 4-nitro-o-phenylene-diamine
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Tall oil, polym., oxidized did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, Tall oil, polym., oxidized is considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
In order to investigate the potential of Tall oil, polym., oxidized for its ability to induce gene mutations the plate incorporation test (experiment I and II) was performed with the 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:
3.16, 10.0, 31.6, 100, 316, 1000 and 2500 μg/plate
(TA 98 and TA 100) in addition for TA 1535, TA 1537 and TA 102: 1.00 μg/plate
Experiment II:
0.632, 2.00, 6.32, 20.0, 63.2, 200, 632 and 2000 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 used in experiment I and II:
- In experiment I toxic effects of the test item were observed at concentrations of 316 μg/plate and higher (with and without metabolic activation), depending on the particular tester strain.
- In experiment II toxic effects of the test item were noted at concentrations of 200 μg/plate and higher (with and without metabolic activation), depending on the particular tester strain.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Tall oil, polym., oxidized at any concentration level, neither in the
presence nor absence of metabolic activation in experiment I and II.
All criteria of validity were met.
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.
