Registration Dossier
Registration Dossier
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EC number: 245-423-3 | CAS number: 23089-26-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
(+/-)-α-Bisabolol (source substance) was considered to be non-mutagenic with and without metabolic activation in bacteria (reference 7.6.1 -1 & reference 7.6.1 -2). (+/-)-α-Bisabolol is considered to be a suitable read across substance for (-)-α-Bisabolol (target substance). Therefore, it can be assumed that (-)-α-Bisabolol is also non-mutagenic with and without metabolic activation in bacteria.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The test item (+/-)-α-Bisabolol is a racemic mixture containing the stereoisomers (+)-α-Bisabolol and (-)-α-Bisabolol. Studies on genetic toxicity were not performed for the target substance (-)-α-Bisabolol due to availability of reliable experimental data for (+/-)-α-Bisabolol. (+/-)-α-Bisabolol is considered to be a suitable read across substance.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance (+/-)-α-Bisabolol, CAS 515-69-5, which was used in the genetic toxicity study, had a purity of 86.8%. No information on impurities is available. The target substance (-)-α-Bisabolol, CAS 23089-26-1, is one of the two stereoisomers of (+/-)-α-Bisabolol.
3. ANALOGUE APPROACH JUSTIFICATION
Experimental data i.e. a genetic toxicity study was available for (+/-)-α-Bisabolol. (+/-)-α-Bisabolol was tested in a bacterial reverse mutation assay according to OECD 471 in Salmonella typhimurium. The test substance was considered to be non-mutagenic with and without metabolic activation in bacteria. The information given on (+/-)-α-Bisabolol is considered to be sufficient to cover the required endpoint information for the target substance (-)-α-Bisabolol. - Reason / purpose for cross-reference:
- read-across source
- 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
- Untreated negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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
- Untreated negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The test item (+/-)-α-Bisabolol is a racemic mixture containing the stereoisomers (+)-α-Bisabolol and (-)-α-Bisabolol. Studies on genetic toxicity were not performed for the target substance (-)-α-Bisabolol due to availability of reliable experimental data for (+/-)-α-Bisabolol. (+/-)-α-Bisabolol is considered to be a suitable read across substance.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance (+/-)-α-Bisabolol, CAS 515-69-5, which was used in the genetic toxicity study, had a purity of 86.8%. No information on impurities is available. The target substance (-)-α-Bisabolol, CAS 23089-26-1, is one of the two stereoisomers of (+/-)-α-Bisabolol.
3. ANALOGUE APPROACH JUSTIFICATION
Experimental data i.e. a genetic toxicity study was available for (+/-)-α-Bisabolol. (+/-)-α-Bisabolol was tested in a bacterial reverse mutation assay according to OECD 471 in Salmonella typhimurium. The test substance was considered to be non-mutagenic with and without metabolic activation in bacteria. The information given on (+/-)-α-Bisabolol is considered to be sufficient to cover the required endpoint information for the target substance (-)-α-Bisabolol. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 500 µg/plate (-S9)
- Vehicle controls validity:
- valid
- Untreated negative 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
- Remarks:
- at 500 µg/plate (-S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 500 µg/plate (-S9)
- Vehicle controls validity:
- valid
- Untreated negative 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
- Remarks:
- at 500 µg/plate (-S9)
- Vehicle controls validity:
- valid
- Untreated negative 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
- Remarks:
- at 500 µg/plate (-S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial Reverse Mutation Test, Ref. 7.6.1 -1
(+/-)-α-Bisabolol (source substance) was tested for its mutagenic potential based on the ability to induce reverse mutations in selected loci in several strains of Salmonella typhimurium in the Ames test according to OECD guideline 471. The Salmonella typhimurium strains used were TA 1535, TA 100, TA 1537 and TA 98. Two series of a standard plate test and two series of a preincubation test were performed. The dose range was 20 -5000 µg/plate for the standard plate tests and 2.5 - 1500 µg/plate for the preincubation tests. All tests were performed with and without metabolic activation (Aroclor induced rat liver S9). No precipitation of the test substance was found. A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) was observed under the experimental conditions. An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either with or without S9 mix. According to the results of the present study, the test substance is not mutagenic in the Ames test.
Bacterial Reverse Mutation Test, Ref. 7.6.1 -2
The mutagenicity of the test item was studied with five mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100, and TA102). The investigations were carried out using the standard plate incorporation assay with and without liver homogenate (S9) from Aroclor 1254 pretreated male rats as metabolic activation system. The test item was dissolved in DMSO and tested in concentrations of 1.5 to 1500 µg per plate in the presence and of 0.5 to 500 µg per plate in the absence of S9. In the absence of S9-mix the test item was bacteriotoxic towards the strains TA1535, TA1537, TA98, and TA100 at 150 µg/plate and towards the strain TA102 at 500 µg/plate. In the presence of S9-mix the test item was bacteriotoxic towards the strains TA1535, TA1537, and TA100 at 500 µg / plate and towards the strains TA98 and TA102 at 1500 μg/plate. Precipitation of the test compound in the plates was not observed. Sodium azide, 2-nitrofluorene, 9-aminoacridine, mitomycin C, and 2-aminoanthracene served as positive controls to confirm the reversion properties and the specificity of the bacterial strains as well as the efficacy of the metabolizing system. In the concentration range investigated, the test item did not induce a significant increase in the mutation frequency of the tester strains in the presence and absence of a metabolic activation system. In conclusion, these results indicate that the test item under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA 1 00, and TA102 in the presence and absence of a metabolizing system.
(+/-)-α-Bisabolol (source substance) is considered to be a suitable read across substance for (-)-α-Bisabolol (target substance). Therefore, it can be assumed that (-)-α-Bisabolol is also non-mutagenic with and without metabolic activation in bacteria.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The results indicate that the substance is non-mutagenic. Based on available data on genetic toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EC) No 2017/776.
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.
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