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EC number: 282-001-8 | CAS number: 84082-55-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lupinus albus, Leguminosae.
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, the test item was found non mutagenic at the maximal concentration of 5000 μg/plate, with and without S9-mix in strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA102 ).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 January- 11 February 2010
- 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
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% S9: S9-mix from the livers of male Sprague Dawley rats
- Test concentrations with justification for top dose:
- Preliminary cytotoxicity testing study: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 100 strain
Main study - Direct plate incorporation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100, TA 102 strains
Confirmatory assay - pre-incubation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile and apyrogen sodium chloride
- Untreated negative controls:
- yes
- Remarks:
- absolute negative control: spontaneous reversion rate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-Anthramine
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM
- Bacteria used in the test was obtained from Unité de Programmation moléculaire et toxicologie génétiuqe CNRS UA 144 (Institut Pasteur)
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 37 °C for 20 minutes
- Exposure duration: Plates were incubated at 37 ± 1 °C for 48-72 h
NUMBER OF REPLICATIONS: Triplicate plates per dose level - Evaluation criteria:
- The result of the test is considererd as negative if the revertant number is below three fold the number of spontaneous reversions for TA 1535 and TA 1537 strains, and below two fold the number of spontaneous reversions fo TA 98, TA 100 and TA 102 strains with and/or without metabolic activation.
The validity criteria are:
- bacteriostatic activity of the highest concentration shall be equal to or less than 75%
- the spontaneous reversion rate of the absolute negative control shall comply with the laboratory's historical control data.
- the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with laboratory's historical control data
The result of the test is considered positive if a concentration- related increase is obtained in one, or several of the 5 strains, with and/or without metabolic activation; a mutagenic effect is taken into acount for a given concentration of the test substance if the number of revertant colonies is at least two fold that of spontaneous revertant colonies number for TA 98, TA 100 and TA 102 and 3 folds for TA 1535 and TA 1537.
All results must be confirmed in an ondependent experiment - Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- 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:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results
negative with metabolic activation
negative without metabolic activation
Under the test conditions, test item there is no evidence of any increase of the number of revertant colonies in the presence of the test substance; without and with metabolic activation for bacterial strains in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102. - Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA102) were exposed to test item, at the following concentrations:
Range finding study: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains
Main study - Direct plate incorporation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains
Confirmatory assay - pre-incubation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains
Metabolic activation system used in this test 10 % S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats. Vehicle and negative and positive control groups were also included in mutagenicity tests.
In a range-finding study, no cytotoxicity exhibited in terms of a clearance in the background lawn or reduction in the revertant colonies. No marked or consistent differences in the number of revertant colonies per plate was observed in various test concentrations and solvent controls of all the tester strains, both with (10% S9 mix) and without exogenous mammalian S9 activation component in the main assays.
The mean numbers of revertant colonies are fell within acceptable ranges for vehicle control treatments. The positive controls of the five tester strains with and without S9 mix exhibited a statistically significant increase in the number of histidine and tryptophan positive colonies, validating the sensitivity of the assay.
Under the test conditions, test item is not considered as mutagenic in this bacterial system.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA 02) were exposed to test item at the following concentrations:
Range finding study: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains
Main study - Direct plate incorporation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains
Confirmatory assay - pre-incubation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains
Metabolic activation system used in this test 10 % S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats. Vehicle and negative and positive control groups were also included in mutagenicity tests.
In a range-finding study, no cytotoxicity exhibited in terms of a clearance in the background lawn or reduction in the revertant colonies. No marked or consistent differences in the number of revertant colonies per plate was observed in various test concentrations and solvent controls of all the tester strains, both with (10% S9 mix) and without exogenous mammalian S9 activation component in the main assays.
The mean numbers of revertant colonies are fell within acceptable ranges for vehicle control treatments. The positive controls of the five tester strains with and without S9 mix exhibited a statistically significant increase in the number of histidine and tryptophan positive colonies, validating the sensitivity of the assay.
Under the test conditions, test item is not considered as mutagenic in this bacterial system.
Justification for classification or non-classification
In a reverse gene mutation assay in bacteria, performed according to OECD guideline 471, test item was found non mutagenic; as a consequence, no classification for mutagenic toxicity is required for the registered substance.
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