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EC number: 946-253-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 January 2015 to 09 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed accoring to OECD Guideline 471 and the GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation
- EC Number:
- 946-253-9
- Molecular formula:
- Not applicable
- IUPAC Name:
- Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Spearmint Essential Oil, ex Mentha spicata
- Physical state: Clear colourless to pale yellow liquid
- Analytical purity: confidental
- Impurities (identity and concentrations): confidental
- Purity test date: confidental
- Lot/batch No.: confidental
- Expiration date of the lot/batch: confidental
- Storage condition of test material: at room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital – 5,6-Benzoflavone induced S9 from Sprague Dawley rat liver
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 50, 158, 500, 1580, 5000 µg/plate
Exp 1 (plate incorporation)
TA1535 - S9 S9 1600, 800, 400, 200, 100 and 50.0 µg/plate
TA1535 +S9 3200, 1600, 800, 400, 200 and 100 µg/plate
TA98 ± S9 1600, 800, 400, 200, 100 and 50.0 µg/plate
TA100 ±S9 S9 1600, 800, 400, 200, 100 and 50.0 µg/plate
TA1537 ±S9 200, 100, 50.0, 25.0, 12.5, 6.25 and 3.13 µg/plate
WP2 uvrA –S9 5000, 2500, 1250, 625, 313 and 156 µg/plate
WP2 uvrA +S9 5000, 2500, 1250, 625 and 313 µg/plate
Exp. 2 (pre incubation)
WP2 uvrA –S9 5000, 2500, 1250, 625, 313, 156 and 78.1 µg/plate
WP2 uvrA + S9 5000, 2500, 1250, 625, 313 and 156 µg/plate
TA1535 + S9 3200, 1600, 800, 400, 200, 100 and 50.0 µg/plate
TA1535 − S9 1600, 800, 400, 200, 100, 50.0 and 25.0 µg/plate
TA98 ± S9 1600, 800, 400, 200, 100, 50.0 and 25.0 µg/plate
TA100 + S9 1600, 800, 400, 200, 100 and 50.0 µg/plate
TA100 − S9 800, 400, 200, 100, 50.0 and 25.0 µg/plate
TA1537 ± S9 400, 200, 100, 50.0, 25.0 and 12.5 µg/plate
Exp. 3 (pre incubation)
TA1535 −S9 25.0, 12.5, 6.25, 3.13, 1.56 and 0.781 µg/plate
TA1535 +S9 100, 50.0, 25.0, 12.5, 6.25 and 3.13 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: compatible with the survival of the bacteria and the S9 metabolic activity
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterile water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
Experiment I: Plate incorporation, Experiment II and III: preincubation
DURATION
- Preincubation period: 30 min
- Exposure duration: 72 h at 37 C
NUMBER OF REPLICATIONS: Three replicates
Solubility was determined in a preliminary test. - Evaluation criteria:
- For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies
with increasing dose levels. - Statistics:
- regression analysis, t test
Results and discussion
Test resultsopen allclose all
- 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:
- 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
- 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
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Precipitation: not detected
RANGE-FINDING/SCREENING STUDIES: the results of the preliminary toxicity test revealed cytotoxicity in some concentration levels, mentioned as thinning of the background lawn. Details can be found below, in section 'Any other information on results including tables'.
COMPARISON WITH HISTORICAL CONTROL DATA: some exceptions, but were considered acceptable
Sterility: confirmed based on absent clonies on additional agar plates. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: PRELIMINARY TOXICITY TEST WITHOUT METABOLIC ACTIVATION
Dose level (µg/plate) |
TA-1535 Rev/pl. |
TA-1537 Rev/pl. |
TA-98 Rev/pl. |
TA-100 Rev/pl. |
WP2uvrA Rev/pl. |
untreated |
21 |
20 |
37 |
169 |
26 |
0.00 |
24 |
23 |
31 |
118 |
24 |
50.0 |
39 |
16* |
35 |
121 |
24 |
158 |
25* |
13* |
36 |
108 |
28 |
500 |
59* |
12* |
26* |
104 |
24 |
1580 |
65* |
12* |
40* |
76* |
18* |
5000 |
50* |
M |
34* |
M |
13* |
*: thinning
of the background lawn
M: microcolony formation
Table 2: PRELIMINARY TOXICITY TEST WITH METABOLIC ACTIVATION
Dose level (µg/plate) |
TA-1535 Rev/pl. |
TA-1537 Rev/pl. |
TA-98 Rev/pl. |
TA-100 Rev/pl. |
WP2uvrA Rev/pl. |
untreated |
19 |
21 |
35 |
169 |
34 |
0.00 |
22 |
27 |
32 |
132 |
31 |
50.0 |
23 |
15* |
28 |
119 |
20 |
158 |
22 |
23* |
46 |
133 |
27 |
500 |
28 |
16* |
31* |
123 |
30 |
1580 |
31* |
12* |
23* |
75* |
22 |
5000 |
13* |
M* |
18* |
13* |
17* |
*: thinning
of the background lawn
M: microcolony formation
**Tables of the main mutagenicity experiments 1, 2 and 3 can be found in the attached document (Tables_Results_Spearmint Spicata) below, section 'Attached background material'.
Applicant's summary and conclusion
- Conclusions:
- negative with and without S9. Spearmint Spicata did not induce reverse mutations in S. typhimurium or E.coli, in the presence and absence of metabolic activation, under the conditions of this test.
- Executive summary:
In a bacterial reverse mutation assay, Spearmint Spicata was tested in order to examine its potential to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli. The following strains were used: TA1535, TA1537, TA98, TA100 and WP2uvrA. Experiments were conducted both in the absence and presence of metabolic activation (liver S9 fraction, induced with phenobarbitone and betanaphthoflavone). A preliminary test was performed in order to determine cytotoxicity and define appropriate concentration levels for the main experiments. Both the plate incorporation and pre incubation methods were used. The study was performed according to the OECD Guideline 471.
No precipitation was seen at all concentrations tested, while some toxicity was detected. Concentrations levels were adapted based on these reults. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method. The positive controls induced marked increases in the No of revertant colonies, which show the validity of this result.
It was concluded that Spearmint Spicata does not show any mutagenic activity under the conditions of this test. Therefore, the test substance does not need to be classified under the conditions of this test according to the criteria outlined in Annex I of 1272/2008/EC (CLP).
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