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EC number: 273-309-3 | CAS number: 68956-56-9
- 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:
- 27 July - 6 August 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with OECD Guideline 471 with deviations: the temperature of the incubator rose to 38.1 °C overnight in Experiment 1; storage temperature of the test article was exceeded to 11.4 °C
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- the temperature of the incubator rose to 38.1 °C overnight in Experiment 1; storage temperature of the test article was exceeded to 11.4 °C
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydrocarbons, terpene processing by-products
- EC Number:
- 273-309-3
- EC Name:
- Hydrocarbons, terpene processing by-products
- Cas Number:
- 68956-56-9
- Molecular formula:
- Not applicable for UVCB substance
- IUPAC Name:
- Hydrocarbons, terpene processing by-products
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Hydrocarbons, terpene processing by-products
- Physical state: Colourless liquid
- Analytical purity: 100 % (sum of terpene hydrocarbons: 89.1%)
- Lot/batch No.: I23-090312
- Expiration date: 9 March 2013
- Storage condition of test material: 2-8 °C, under nitrogen, protected from light
Constituent 1
Method
- Target gene:
- His+ for S. typhimurium
Species / strain
- 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:
- other: histidine dependence, rfa character, uvrB character and resistance to ampicillin or ampicillin plus tetracycline
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 % S9 mix; S9 fraction prepared from liver homogenates of rats induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- Experiment 1: 5, 15.81, 50, 158.1, 500, 1581 and 5000 μg/plate, with and without S9 mix in all strains (plate incorporation method)
Experiment 2: 0.4096, 1.024, 2.56, 6.4, 16, 40 and 100 µg/plate, with S9 mix (pre-incubation method) and without S9 mix (plate incorporation method) in all strains - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (Dimethyl sulphoxide)
- Test article stock solutions were prepared by formulating test item in DMSO under subdued lighting conditions with the aid of vortex mixing, immediately prior to assay to give the maximum required treatment solution concentration. Subsequent dilutions were made using DMSO. The test article solutions were protected from light and used within approximately 5 h of initial formulation.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Nitrofluorene: 5 μg/plate for TA98; Sodium azide: 2 μg/plate for TA100 and TA1535; 9-Aminoacridine: 50 μg/plate for TA1537; mitomycin C: 0.2 μg/plate for TA102
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Benzo[a]pyrene: 10 μg/plate for TA98; 2-Aminoanthracene: 5 μg/plate for TA100, TA1535 and TA1537 and 20 μg/plate for TA102
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: Strains TA98, TA1535 and TA1537 were originally obtained from the UK NCTC. Strains TA100 and TA102 were derived from cultures originally obtained from Covance Laboratories Inc., USA.
METHOD OF APPLICATION: In agar (direct plate incorporation and preincubation method)
DURATION
- Preincubation period: 20 minutes at 37±1 °C
- Incubation period: 3 days at 37±1 °C for both direct plate incorporation and preincubation methods
NUMBER OF REPLICATIONS:
-3 plates/dose for treatment and positive controls
- 5 plates/dose for vehicle control
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn of treated plates was inspected for signs of toxicity.
OTHER: Colonies were counted electronically using a Sorcerer Colony Counter (Perceptive Instruments). - Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
1. When assessed using Dunnett's test, an increase in revertant numbers gave a significant response (p ≤ 0.01) which was concentration related.
2. The positive trend/effects described above were reproducible.
- The test article was considered positive in this assay if all of the above criteria were met.
- The test article was considered negative in this assay if none of the above criteria were met.
- Results which only partially satisfied the above criteria were dealt with on a case-by-case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. - Statistics:
- - Dunnett's test was used to compare the counts at each concentration with the control. The presence or otherwise of a concentration response was checked by non-statistical analysis, up to limiting levels (for example toxicity, precipitation or 5000 μg/plate).
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: None
CYTOTOXICITY:
- Experiment 1: Toxicity was observed at 50 μg/plate and above in all strains in the absence and presence of S-9.
- Experiment 2: Toxicity was observed at 16 μg/plate and above in strains TA100 and TA1535 in the presence of S-9; 40 μg/plate and above in strains TA100, TA1535 and TA102 in the absence of S-9 and strain TA1537 in the absence and presence of S-9; and at 100 μg/plate in strain TA98 in the absence and presence of S-9 and strain TA102 in the presence of S-9.
COMPARISON WITH HISTORICAL CONTROL DATA:
- Results were compared with historical data from the period February 2008 - July 2009. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
See attached Document for Tables of Results
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the test conditions, Hydrocarbons, terpene processing by-products batch I23-090312 is not considered as mutagenic in S. typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA102) strains. - 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 (TA 1535, TA 1537, TA 98, TA 100 and TA 102) and were exposed to Hydrocarbons, terpene processing by-products batch I23-090312 at the following concentrations:
- Experiment 1: 5, 15.81, 50, 158.1, 500, 1581 and 5000 μg/plate, with and without S9 mix in all strains (plate incorporation method)
- Experiment 2: 0.4096, 1.024, 2.56, 6.4, 16, 40 and 100 µg/plate, with S9 mix (pre-incubation method) and without S9 mix (plate incorporation method) in all strains
Metabolic activation system used in this test was 10% S9 mix; S9 fraction prepared from liver homogenates of rats induced with Aroclor 1254. Vehicle and positive control groups were also included in mutagenicity tests.
In Experiment 1, toxicity was observed at 50 μg/plate and above in all strains in the absence and presence of S-9. In Experiment 2, toxicity was observed at 16 μg/plate and above in strains TA100 and TA1535 in the presence of S-9; 40 μg/plate and above in strains TA100, TA1535 and TA102 in the absence of S-9 and strain TA1537 in the absence and presence of S-9; and at 100 μg/plate in strain TA98 in the absence and presence of S-9 and strain TA102 in the presence of S-9. Following treatments of all the test strains in the absence and presence of S-9, only Experiment 2 treatments of strain TA102 in the presence of S-9 at 2.56 μg/plate resulted in an increase in revertant numbers that was statistically significant when the data were analysed at the 1 % level using Dunnett’s test, however this was not concentration related or reproducible and was of insufficient magnitude to be considered as clear evidence of mutagenic activity in this assay system. No other increases in revertant numbers were observed that were statistically significant when the data were analysed at the 1% level using Dunnett’s test. The positive and vehicle controls induced the appropriate responses in the corresponding strains indicating the validity of the study.
Under the test conditions, Hydrocarbons, terpene processing by-products batch I23-090312 was not considered as mutagenic in this bacterial system.
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