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EC number: 443-860-6 | CAS number: 302776-68-7
- 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:
- 2002-12-10 until 2003-01-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 443-860-6
- EC Name:
- -
- Cas Number:
- 302776-68-7
- Molecular formula:
- C24 H31 N O4
- IUPAC Name:
- hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate
Constituent 1
Method
- Target gene:
- For Salmonella typhimurium strains, the amino acid histidine locus is the target gene, for the E.coli WP2 uvrA strain the amino acid tryptophan locus is the target gene.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: All strains have a defective excision repair system (uvrB) which results in greatly enhanced sensitivity to some mutagens and considerably reduced hydrophilic polysaccharide layer (rfa), which Ieads to an increase in permeability to lipophilic substances.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: Deficient excision repair.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9- mix
- Test concentrations with justification for top dose:
- In the standard plate test (STP): 0; 20; 100; 500; 2500 and 5000 µg/plate
In the preincubation test (PIT): 0; 4; 20; 100; 500 and 2500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle. It has already been demonstrated that DMSO is to be suitable to be used in bacterial reverse mutation tests and historical control data exists.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2- aminoanthracene (2-AA)
- Remarks:
- 2-aminoanthracene (2-AA) was used in all strains in the presence of S-9 mix.
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- N-ethyl-N-nitro-N-nitrosoguanidine was used in the TA 1535 and in the TA 100 strains without the presence of S-9 mix.
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 9-aminoacridine was used in the TA 1537 strain without the presence of S-9 mix.
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 4-nitroquinoline-N-oxide was used in the E.coli strain without the presence of S-9 mix.
- Positive control substance:
- other: 4-nitro-o-phenylendiamine (NOPD)
- Remarks:
- 4-nitro-o-phenylendiamine was used in the TA 98 strain without the presence of S-9 mix.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); in suspension (preincubation)
DURATION
- Preincubation period: In the plate incorporation plate test (standard plate test) there is no preincubation period (with the test substance). In the preincubation test: 20 min., before the mixture of the bacteria, test substance and medium are poured to the selective minimal agar.
SELECTION AGENT (mutation assays): Minimal agar without histidine or tryptophan.
NUMBER OF REPLICATIONS: 3
Indication for mutagenicity: An increase in the number of revertants (his+), trp(+).
DETERMINATION OGF CYTOTOXICITY:
3. Toxicity is detected by a:
- decrease in the number of revertants
- clearing or diminution of the background lawn
- reduction in the titer
All these parameters were recorded for all test groups both with and without S-9 mix in all experiments. - Evaluation criteria:
- 1. The test chemical is considered positive in this assay if the following criteria is met:
A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either with or without S-9 mix.
2. A test substance is generally considered no mutagenic in this test if:
The numbers of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments which were carried out independently of each other. - Statistics:
- The mean number of revertant colonies per plate, titer, and the standard deviations were calculated for all dose groups as well as for the positive and negative (vehicle) controls in all experiments.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A slight decrease in the number of revertants, was occasionally observed from about 2500 µg/plate onward.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A slight decrease in the number of revertants, indicating cytotoxicity, was occasionally observed from about 2500 µg/plate onward.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS:
- Precipitation: Precipitation of the test substance was found from about 100 µg/plate onward. As long as precipitation did not interfere with the colony scoring, 5 mg/plate was generally selected and analyzed as the maximum dose (in the standard plate test). - Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
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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