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EC number: 284-545-1 | CAS number: 84929-61-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Daucus carota, Umbelliferae.
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test: non mutagenic (OECD 471, GLP, K, rel. 1).
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:
- April- May 2016
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- January 2015
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Physical state: pale yellow to amber liquid
- Purity: 100%
- Lot/batch No.: 0115/1
- Production date: 07 January 2015
- Date of receipt: 29 February 2016
- Expiration date of the lot/batch: 01 February 2018
- Stability: Stable under normal storage conditions - Target gene:
- Histidine and Tryptophane
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 % S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats
- Test concentrations with justification for top dose:
- - TA1535, TA1537, TA98, TA100 and E. Coli WP2: 50, 150, 500, 1500, 3500 and 5000 μg/plate, with and without S9-mix
At 5000 µg/plate important bacteriostatic activity was observed, thus a dose at 3500 µg/plate was also used. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9,10-dimethylbenzanthracene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Antramine (2µg/plate with S9 metablica activation), 9-Aminoacridine (50µg/plate without metabolic activation), cis-Platinum (II) Diammine dichloride (1µg/plate without metabolica activation)
- Details on test system and experimental conditions:
- SOURCE OF THE TEST SYSTEM: Strains were obtained from MOLTOX TM.
METHOD OF APPLICATION: In agar (plate incorporation); preincubation
NUMBER OF REPLICATES: Controls and treatment were performed in triplicate.
DURATION
- Preincubation period: 30 minutes at 37 °C, with shaking
- Incubation period: Plates were inverted and incubated at 37 °C in the dark for 48-72 hour in both direct plate and preincubation methods. - Evaluation criteria:
- The following criteria were checked to validate the study:
- the bacteriostatic activity of the highest concentration tested shall be equal to or less than 75 %,
- the spontaneous reversion rate of the absolute negative control shall comply with the historical values of the laboratory,
- the spontaneous reversion rate of the solvent shall not be statistically different from absolute negative control,
- the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with the historical values of the laboratory.
- Negative and positive values should not show significant difference with the historical values of the laboratory (± 2 standard deviations). - Statistics:
- No data
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- moderate thinning of the background bacterial lawn at 5000 µg/plate
- 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:
- moderate thinning of the background bacterial lawn at 3500 and 5000µg/plate
- 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:
- moderate thinning of the background bacterial lawn at 3500 and 5000µg/plate
- 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:
- moderate thinning of the background bacterial lawn at 3500 and 5000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- moderate thinning of the background bacterial lawn at 3500 and 5000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary cytotoxicity testing (Strain TA100):
Bacteriostatic test has been performed, in case of bacteriostatic activity the concentration, the highest concentration that will be retained for the study is the concentration that induices a bacteriostatic activity of 75% or less.
Bacteriostatic activity has been observed at 500µg/plate - Conclusions:
- Under the test conditions, the test item is not considered as mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2 (uvrA-) (pKM 101) strains without, or with metabolic activation.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains ofSalmonella typhimurium(TA1535, TA1537, TA98, TA100 and E.coli WP2) were exposed to test item, carrot see oil (F7070G) at the following concentrations:
- TA1535, TA1537, TA98, TA100 and E.coli WP2: 50, 150, 500, 1500, 3500 and 5000 μg/plate, with and without S9-mix
Metabolic activation system used in this test 10 % S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats . Vehicle, negative and positive control groups were also included in mutagenicity tests.
In Experiments , following the treatment,evidence of toxicity was observed at 5000 μg/plate and/or 3500 μg/plate in all strains in the absence and presence of S-9.
The mean numbers of revertant colonies are fell within acceptable ranges for vehicle control treatments, and were elevated by positive control treatments.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
Under the test conditions, test item is not considered as mutagenic in this bacterial system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Table 7.6/1: Summary of genotoxicity test
Test n° |
Test / Guideline Reliability |
Focus |
Strains tested |
Metabolic activation |
Test concentration |
Statement |
1 Savineau, 2016 |
Ames Test (OECD 471) K, rel. 1 |
Gene mutation |
TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA- |
-S9 +S9 |
Up to cytotoxic or highest recommended concentration |
-S9 : non mutagenic +S9 : non mutagenic |
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains ofSalmonella typhimurium(TA1535, TA1537, TA98, TA100 and E.coli WP2) were exposed to test item, carrot seed oil (F7070G) at the following concentrations:
- TA1535, TA1537, TA98, TA100 and E.coli WP2: 50, 150, 500, 1500, 3500 and 5000 μg/plate, with and without S9-mix
Metabolic activation system used in this test 10 % S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats. Vehicle, negative and positive control groups were also included in mutagenicity tests.
In Experiments, following the treatment, evidence of toxicity was observed at 5000 μg/plate and/or 3500 μg/plate in all strains in the absence and presence of S-9.
The mean numbers of revertant colonies are fell within acceptable ranges for vehicle control treatments, and were elevated by positive control treatments.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
Under the test conditions, test item is not considered as mutagenic in this bacterial system.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available data, the registered substance does not require classification for mutagenicity according to the Regulation (EC) No. 1272/2008 (CLP).
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