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REACH

Potassium Lauroyl Wheat Amino Acids

EC number: 934-512-9 | CAS number: -

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Based on the study results, the test substance was considered to be non-mutagenic in the Ames test, with and without metabolic activation.

Link to relevant study records

Reference

Endpoint:: in vitro gene mutation study in bacteria
Type of information:: experimental study
Adequacy of study:: key study
Study period:: From September 25, 2017 to October 23, 2017
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: guideline study
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
Qualifier:: according to guideline
Guideline:: JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:: no
GLP compliance:: yes (incl. QA statement)
Type of assay:: bacterial reverse mutation assay
Species / strain / cell type:: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Additional strain / cell type characteristics:: not specified
Metabolic activation:: with and without
Metabolic activation system:: Rat liver homogenate metabolizing system (10% liver S9 in standard co-factors)
Test concentrations with justification for top dose:: Experiment 1: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate (Presence and absence of S9)
Experiment 2: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate (Presence and absence of S9)
The maximum concentration was 5000 µg/plate (the maximum recommended dose level).
Vehicle / solvent:: In solubility checks performed in–house, the test item was noted as insoluble sterile distilled water at 50 mg/mL but fully soluble in dimethyl sulphoxide at the same concentration. Dimethyl sulphoxide was selected as the vehicle.
Untreated negative controls:: yes
Negative solvent / vehicle controls:: yes
Remarks:: Identity: Dimethyl sulphoxide, Supplier: Fisher Scientific, Batch number (purity): 1710280 (>99%), Expiry: 06/2022
Positive controls:: yes
Positive control substance:: 4-nitroquinoline-N-oxide; 9-aminoacridine; N-ethyl-N-nitro-N-nitrosoguanidine; benzo(a)pyrene; other: Identity: 2-Aminoanthracene (2AA), CAS No.: 613-13-8, Batch number: STBB1901M9, Purity: 97.5%, Expiry date: 08 October 2019, Solvent: DMSO, Concentration: 1 µg/plate for TA100, 2 µg/plate for TA1535 and TA1537 , 10 µg/plate for WP2uvrA
Details on test system and experimental conditions:: Bacteria
The five strains of bacteria used, and their mutations, are as follows:
1) Salmonella typhimurium
Strains - Genotype - Type of mutations indicated
TA1537 - his C 3076; rfa-; uvrB-: - frame shift
TA98 - his D 3052; rfa-; uvrB-; - R-factor
TA1535 - his G 46; rfa-; uvrB-: - base-pair substitution
TA100 - his G 46; rfa-; uvrB-;R-factor

2) Escherichia coli
Strain - Genotype - Type of mutations indicated
WP2uvrA - trp-; uvrA-: - base-pair substitution

All of the Salmonella strains are histidine dependent by virtue of a mutation through the histidine operon and are derived from S. typhimurium strain LT2 through mutations in the histidine locus. Additionally due to the "deep rough" (rfa-) mutation they possess a faulty lipopolysaccharide coat to the bacterial cell surface thus increasing the cell permeability to larger molecules. A further mutation, through the deletion of the uvrB- bio gene, causes an inactivation of the excision repair system and a dependence on exogenous biotin. In the strains TA98 and TA100, the R factor plasmid pKM101 enhances chemical and UV-induced mutagenesis via an increase in the error prone repair pathway. The plasmid also confers ampicillin resistance which acts as a convenient marker (Mortelmans and Zeiger, 2000). In addition to a mutation in the tryptophan operon, the E. coli tester strain contains a uvrA- DNA repair deficiency which enhances its sensitivity to some mutagenic compounds. This deficiency allows the strain to show enhanced mutability as the uvrA repair system would normally act to remove and repair the damaged section of the DNA molecule (Green and Muriel, 1976 and Mortelmans and Riccio, 2000).

The bacteria used in the test were obtained from:
1) University of California, Berkeley, on culture discs, on 04 August 1995.
2) British Industrial Biological Research Association, on a nutrient agar plate, on 17 August 1987.
All of the strains were stored at approximately -196 °C in a Statebourne liquid nitrogen freezer, model SXR 34. In this assay, overnight sub-cultures of the appropriate coded stock cultures were prepared in nutrient broth (Oxoid Limited; lot number 1865318 05/21) and incubated at 37 °C for approximately 10 h. Each culture was monitored spectrophotometrically for turbidity with titres determined by viable count analysis on nutrient agar plates.
In this assay, overnight sub-cultures of the appropriate coded stock cultures were prepared in nutrient broth (Oxoid Limited; lot number 1865318 05/21) and incubated at 37°C for approximately 10 h. Each culture was monitored spectrophotometrically for turbidity with titres determined by viable count analysis on nutrient agar plates.
Evaluation criteria:: There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1) A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2) A reproducible increase at one or more concentrations.
3) Biological relevance against in-house historical control ranges.
4) Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5) Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out of historical range response (Cariello and Piegorsch, 1996)).

A test substance will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgment about test substance activity. Results of this type will be reported as equivocal.
Statistics:: Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control. Values that the program concluded as statistically significant but were within the in-house historical profile were not reported.
: Key result
Species / strain:: other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A
Metabolic activation:: with and without
Genotoxicity:: negative
Cytotoxicity / choice of top concentrations:: no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:: valid
Untreated negative controls validity:: valid
Positive controls validity:: valid
Conclusions:: Under the study conditions, the test substance was considered to be non-mutagenic in the Ames test, with and without metabolic activation.
Executive summary:: A study was conducted to determine the genotoxic potential of the test substance, 'potassium lauroyl wheat amino acids' (active: 69.2%) using Ames test, according to OECD Guideline 471, EU Method B13/14 and the USA, EPA OCSPP harmonized guideline, in compliance with GLP. Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test substance using both the Ames plate incorporation (Experiment 1) and pre-incubation (Experiment 2) methods at eight dose levels (i.e., 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate), in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (i.e., 10% liver S9 in standard co-factors). The dose range for Experiment 1 was predetermined and ranged from 1.5 to 5000 µg/plate. The experiment was repeated on a separate day using fresh cultures of the bacterial strains and fresh test substance formulations. Following the results of Experiment 1 (plate incorporation method), the dose range for Experiment 2 (pre-incubation method) was decided and kept the same (i.e., ranging from 1.5 to 5000 µg/plate), in order to achieve both four non‑toxic dose levels and the toxic limit of the test substance following the change in test methodology. The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies generally within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9 -mix were validated. The maximum dose level of the test substance in the first experiment was selected as the maximum recommended dose level of 5000 µg/plate. In Experiment 1/first mutation test (plate incorporation method) the test substance induced a toxic response, as weakened bacterial background lawns to all of the Salmonella strains in both the absence and presence of metabolic activation (S9 -mix) from 1500 µg/plate (TA100, TA1535 and TA1537) and at 5000 µg/plate (TA98). No toxicity was noted to Escherichia coli strain WP2uvrA. These results were not indicative of toxicity sufficiently severe enough to prevent the test substance being tested up to the maximum recommended dose level of 5000 µg/plate in the second mutation test/Experiment 2 (pre. Results from Experiment 2, showed that the test substance again induced a toxic response with weakened bacterial background lawns noted in the absence of S9 -mix from 150 µg/plate (TA1537), 500 µg/plate (TA100, TA1535 and TA98) and at 5000 µg/plate (WP2uvrA). In the presence S9 -mix weakened bacterial background lawns were noted from 500 µg/plate (TA100, TA1535 and TA1537), 1500 µg/plate (TA98) and at 5000 µg/plate (WP2uvrA). The sensitivity of the bacterial tester strains to the toxicity of the test substance varied slightly between strain type, exposures with or without S9 -mix and experimental methodology. A test substance precipitate (greasy in appearance) was noted from 5000 µg/plate, this observation did not prevent the scoring of revertant colonies. There were no biologically relevant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test substance, either with or without metabolic activation (S9 -mix) in Experiment 1. Similarly, no biologically relevant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test substance, either with or without metabolic activation (S9 -mix) in Experiment 2. Statistically significant increases in TA1535 revertant colony frequency were observed in both the presence and absence of S9 -mix at 1500 µg/plate in Experiment 1. These increases were considered to have no biological relevance because weakened bacterial background lawns were also noted. Therefore the response would be due to additional histidine being available to His- bacteria allowing these cells to undergo several additional cell divisions and presenting as non-revertant colonies. A minor statistical value was also noted to TA1535 in Experiment 2 (presence of S9 -mix only) at 5 µg/plate, however the individual revertant counts were within the in-house historical vehicle/untreated control values for the strain and were, therefore considered of no biological relevance. Under the study conditions, the test substance was considered to be non-mutagenic in the Ames test, with and without metabolic activation (Envigo, 2017).

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:: no study available

Additional information

A study was conducted to determine the genotoxic potential of the test substance, 'potassium lauroyl wheat amino acids' (active: 69.2%) using Ames test, according to the OECD Guideline 471, EU Method B13/14 and the USA, EPA OCSPP harmonized guideline, in compliance with GLP. Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test substance using both the Ames plate incorporation (Experiment 1) and pre-incubation (Experiment 2) methods at eight dose levels (i.e., 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate), in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (i.e., 10% liver S9 in standard co-factors). The dose range for Experiment 1 was predetermined and ranged from 1.5 to 5000 µg/plate. The experiment was repeated on a separate day using fresh cultures of the bacterial strains and fresh test substance formulations. Following the results of Experiment 1 (plate incorporation method), the dose range for Experiment 2 (pre-incubation method) was kept the same (i.e., ranging from 1.5 to 5000 µg/plate), in order to achieve both four non‑toxic dose levels and the toxic limit of the test substance following the change in test methodology. The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies generally within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9 -mix were validated. The maximum dose level of the test substance in the first experiment was selected as the maximum recommended dose level of 5000 µg/plate. In Experiment 1/first mutation test (plate incorporation method) the test substance induced a toxic response as weakened bacterial background lawns to all of the Salmonella strains in both the absence and presence of metabolic activation (S9 -mix) from 1500 µg/plate (TA100, TA1535 and TA1537) and at 5000 µg/plate (TA98). No toxicity was noted to Escherichia coli strain WP2uvrA. These results were not indicative of toxicity sufficiently severe enough to prevent the test substance being tested up to the maximum recommended dose level of 5000 µg/plate in the second mutation test/Experiment 2 (pre. Results from Experiment 2, showed that the test substance again induced a toxic response with weakened bacterial background lawns noted in the absence of S9 -mix from 150 µg/plate (TA1537), 500 µg/plate (TA100, TA1535 and TA98) and at 5000 µg/plate (WP2uvrA). In the presence S9 -mix weakened bacterial background lawns were noted from 500 µg/plate (TA100, TA1535 and TA1537), 1500 µg/plate (TA98) and at 5000 µg/plate (WP2uvrA). The sensitivity of the bacterial tester strains to the toxicity of the test substance varied slightly between strain type, exposures with or without S9 -mix and experimental methodology. A test substance precipitate (greasy in appearance) was noted from 5000 µg/plate, this observation did not prevent the scoring of revertant colonies. There were no biologically relevant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test substance, either with or without metabolic activation (S9 -mix) in Experiment 1. Similarly, no biologically relevant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test substance, either with or without metabolic activation (S9 -mix) in Experiment 2. Statistically significant increases in TA1535 revertant colony frequency were observed in both the presence and absence of S9 -mix at 1500 µg/plate in Experiment 1. These increases were considered to have no biological relevance because weakened bacterial background lawns were also noted. Therefore the response would be due to additional histidine being available to His- bacteria allowing these cells to undergo several additional cell divisions and presenting as non-revertant colonies. A minor statistical value was also noted to TA1535 in Experiment 2 (presence of S9 -mix only) at 5 µg/plate, however the individual revertant counts were within the in-house historical vehicle/untreated control values for the strain and were, therefore considered of no biological relevance. Under the study conditions, the test substance was considered to be non-mutagenic in the Ames test, with and without metabolic activation (Envigo, 2017).

Justification for classification or non-classification

Based on the absence of mutagenic response in an vitro Ames study, the test substance, 'potassium lauroyl wheat amino acids', does not warrant classification for genotoxicity, according to the EU CLP (Regulation 1272/2008/EC).

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