Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 285-364-0 | CAS number: 85085-34-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Abies balsamea, Pinaceae.
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Oct 2017 - 09 Nov 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- in accordance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 31 May 2008
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Health Effects Test Guidelines, OPPTS 870.5100, “Bacterial Reverse Mutation Test”, EPA 712-C-98-247
- Version / remarks:
- August 1998
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fir, Abies balsamea, ext.
- EC Number:
- 285-364-0
- EC Name:
- Fir, Abies balsamea, ext.
- Cas Number:
- 85085-34-3
- IUPAC Name:
- Fir Balsam Oil
- Test material form:
- liquid
- Details on test material:
- Name of test material as cited in study report: Fir Needle Oil Canadian (Fir, Abies Balsamea, ext)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Botanical source and Lot# 67919
- Expiration date of the lot/batch: 13 septembre 2018
- Purity test date: UVCB, considered 100% pure
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (15-25 °C, ≤ 70 RH%), protected from light, avoid contact with iron.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was dissolved in N,N-Dimethylformamide (DMF) at a concentration of 100 mg/mL. It was then diluted in the same solvent to prepare the required test solutions
Method
- Target gene:
- - S. typhimurium: Histidine gene
- Escherichia coli: Tryptophan gene
Species / strain
- 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:
- Cofactor-supplemented post-mitochondrial S9 fraction (prepared from the livers of phenobarbital/β-naphthoflavoneinduced rats).
- Test concentrations with justification for top dose:
- Concentrations were selected on the basis of the Preliminary Solubility Test and Preliminary Range Finding Test (Informatory Toxicity Test).
Based on the results of the preliminary tests, a 100 mg/mL stock solution was prepared in DMF. At least nine test concentrations were prepared by successive dilutions of the stock solution, to obtain lower doses. The maximum test concentration was 5000 μg test item/plate.
Examined concentrations in the Initial Mutation Test were 500, 158.1, 50, 15.81, 5, 1.581, 0.5 and 0.1581 μg/plate at Salmonella typhimurium strains with and without metabolic activation. Moreover the examined concentrations were 5000, 1581, 500, 158.1, 50, 15.81, 5 and 1.581 μg/plate at Escherichia coli WP2 uvrA strain with and without metabolic activation.
Examined concentrations in the Confirmatory Mutation Test were 500, 158.1, 50, 15.81, 5, 1.581, 0.5, 0.1581 and 0.05 μg/plate at Salmonella typhimurium strains with and without metabolic activation and 5000, 1581, 500, 158.1, 50, 15.81, 5 and 1.581 μg/plate at Escherichia coli WP2 uvrA strain with and without metabolic activation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: N,N-Dimethylformamide (DMF)
- Justification for choice of solvent/vehicle: Based on results of a compatibility test, the test item was dissolved in N,N-Dimethylformamide (DMF) at a concentration of 100 mg/mL.
Compatibility test: The solubility of the test item was examined using Distilled water, Dimethyl sulfoxide (DMSO) and N,N-Dimethylformamide (DMF). Insolubility was detected at 100 mg/mL concentration using Distilled water. At the same concentration the test item was formed emulsion with DMSO and was soluble (clear solution) using DMF.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene-diamine (NPD) and 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: 48 h.
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: a decrease in the number of revertants and a reduction of the bacterial background lawn - Rationale for test conditions:
- According to OECD TG 471
- Evaluation criteria:
- The colony numbers on the untreated / negative (vehicle / solvent) / positive control and the test plates will be determined by manual counting. Visual examination of the plates will also be performed; precipitation or signs of growth inhibition (if any) will be recorded and reported. Mean values, appropriate standard deviations and mutation factors will be calculated for each concentration level of the test item and for the controls.
Criteria for Validity:
The study is considered valid if:
- the number of revertant colonies of the negative (vehicle / solvent) and positive controls are in the historical control range in all strains of the main tests;
- at least five analyzable concentrations are presented in all strains of the main tests.
Criteria for a Positive Response:
A test item is considered mutagenic if:
- a dose–related increase in the number of revertants occurs and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
An increase is considered biologically relevant if:
- the number of reversions is more than two times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA98, TA100 and
Escherichia coli WP2 uvrA bacterial strains;
- the number of reversions is more than three times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA1535 and TA1537 bacterial strains.
Criteria for a Negative Response:
A test article is considered non-mutagenic if:
- the total number of revertants in tester strain Salmonella typhimurium TA98, TA100 or Escherichia coli WP2 uvrA is not greater than two times the concurrent vehicle control, and the total number of revertants in tester strain Salmonella typhimurium TA1535 or TA1537 is not greater than three times the concurrent vehicle control;
- the negative response should be reproducible in at least one follow up experiment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA98, TA100, TA1535, TA1537, and Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Plate incorporation method (Initial Mutation Test)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slightly reduced background lawn development
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: See vehicle control
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Pre-incubation method (Confirmatory Mutation Test)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slightly reduced background lawn development
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: See vehicle control
- Positive controls validity:
- valid
- Additional information on results:
- CYTOTOXICITY:
In the Initial Mutation Test slightly reduced background lawn was observed in all Salmonella typhimurium strains on the plates at 500 and 158.1 μg/plate concentration with and without metabolic activation and in Salmonella typhimurium TA100, TA1535 and TA1537 strains at 500, 158.1 and 50 μg/plate concentration without metabolic activation.
In the Confirmatory Mutation Test reduced/slightly reduced background lawn was observed in all Salmonella typhimurium strains on the plates at 500 and 158.1 μg/plate concentration with metabolic activation and at 500, 158.1, 50 and 15.81 μg/plate concentration without metabolic activation. The same effect was detected in Escherichia coli WP2 uvrA strain without metabolic activation at 5000, 1581 and 500 μg/plate concentrations and slightly reduced background lawn was observed with metabolic activation at 5000 μg/plate concentration.
Applicant's summary and conclusion
- Conclusions:
- The reported data of this mutagenicity assay show that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
In conclusion, the test item Fir Needle Oil Canadian (Batch Number: 67919) has no mutagenic activity on the growth of the bacterial strains under the test conditions used in this study. - Executive summary:
The test item was tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay.
The experiments were carried out using histidine-requiring auxotroph strains of Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537) and the tryptophan-requiring auxotroph strain of Escherichia coli(Escherichia coli WP2 uvrA) in the presence and absence of a post mitochondrial supernatant (S9 fraction) prepared from the livers of phenobarbital/beta-naphthoflavone-induced rats.
The study included a Preliminary Compatibility Test, a Preliminary Range Finding Test (Informatory Toxicity Test), an Initial Mutation Test (Plate Incorporation Method) and a Confirmatory Mutation Test (Pre-Incubation Method).
Based on the results of the Compatibility Test, the test item was dissolved in N,N-Dimethylformamide (DMF) at a concentration of 100 mg/mL.Concentrations of 5000; 2500; 1000; 316; 100; 31.6 and 10 µg/plate were examined in the Range Finding Test in tester strains Salmonella typhimuriumTA100 and TA98 in the absence and presence of metabolic activation.
Based on the results of the Range Finding Test, the test item concentrations in the Initial Mutation Testwere 500, 158.1, 50, 15.81, 5, 1.581, 0.5 and 0.1581μg/plate at Salmonella typhimurium strainswith and without metabolic activation.Moreover, the examined concentrations were 5000, 1581, 500, 158.1, 50 15.81, 5 and 1.581 μg/plate at Escherichia coli WP2 uvrA strain with and without metabolic activation.
Examined concentrations in the Confirmatory Mutation Test were 500, 158.1, 50, 15.81, 5, 1.581, 0.5, 0.1581 and 0.05μg/plate at Salmonella typhimurium strains with and without metabolic activation and 5000, 1581, 500, 158.1, 50, 15.81, 5 and 1.581 μg/plate at Escherichia coli WP2 uvrA strain with and without metabolic activation.
No precipitate was observed in the main testsin all examined strains with and without metabolic activation.
Inhibitory, cytotoxic effect of the test item (slightly reduced background lawn development) was observed in theInitial Mutation Testin all examined Salmonella typhimurium strains with and without metabolic activation and reduced / slightly reduced background lawn development was observed in the Confirmatory Mutation Test in all examined strains with and without metabolic activation at some concentrations.
In the Initial Mutation Test and Confirmatory Mutation Test, the number of revertant colonies did not show any biologically relevant increase compared to the solvent controls. There were no consistent dose-related trends and no indication of any treatment-related effect.
The mean values of revertant colonies of the negative (vehicle/solvent) control plates were within the historical control range, the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was checked by a plating experiment in each test. At least five analysable concentrations were presented in all strains of the main tests, the examined concentration range was considered to be adequate. The study was considered to be valid.
The reported data of this mutagenicity assay show that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
In conclusion, the test item Fir Needle Oil Canadian (Batch Number: 67919) has no mutagenic activity on the growth of the bacterial strains under the test conditions used in this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.