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Diss Factsheets
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EC number: 217-421-2 | CAS number: 1843-05-6
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The substance is not mutagenic in the Ames test and does not cause chromosome aberrations in vitro. The methylated analogue did not cause gene mutations in mammalian cells in vitro (Seyfried, 2006).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames Test
The key study for bacterial mutagenicity was performed according to OECD Guideline 471 and GLP (1991). Doses were 625, 1250, 2500, and 5000 µg/plate and DMSO was used as vehicle. No independent repeat experiment, but a separate toxicity test with two strains is reported. Strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A were tested both in the presence and absence of liver S9 mix prepared from Arochlor-induced rats. No significant toxicity and no increase in mutant frequency were observed. Positive and negative control experiments confirmed the validity of the results.
Results of a GLP-compliant Ames test (OECD 471) have been made public by MHLW (Japan). Applied doses were 313, 6235, 1250, 2500 and 5000 μg/plate in the presence and absence of metabolic activation. No indication of mutagenicity was observed. A third Ames assay was performed using tester strains TA98 and TA 100 (Nakajima, 2006). In this assay, octabenzone did not cause a two-fold increase in mutant frequency, which is the threshold for identification as a mutagen.
Chromosomal Aberration
Reliable data on clastogenicity in mammalian cells in vitro is available from two OECD 473 guideline and GLP compliant study in human lymphocytes (2001) and in Chinese hamster lung fibroblasts (MHLW Japan). The substance was found to be non clastogenic.
Mouse Lymphoma Assay
Reliable data on mutagenicity in mammalian cells in vitro is available for the short-chain analogue oxybenzone (2-hydroxy-4 (methoxy)phenyl](phenyl)methanone). It is of better solubility in water and of lower molecular weight because it carries a methyl group instead of a non-branched C8-alkyl chain. As an unbranched alkyl chain is not a structural alert for genotoxicity, it is acceptable to conclude on the outcome of the in-vitro mutagenicity study. The toxicokinetic investigation showed that octabenzone is metabolized via glucuronidation at the phenolic hydroxy group (Patel, 1968). In contrast to sulfonatiation or epoxidation, glucuronidation is not known to create reactive (genotoxic) metabolites. For oxybenzone, no mutagenicity was observed in the mouse-lymphoma assay (OECD 476). Tested doses were 22, 29, 37, 45 and 52 µg/mL (without S9) and 18, 24, 31, 37, 44 and 50 µg/mL (with S9) using DMSO as vehicle. A less than 3-fold increase occurred at highly toxic concentrations in the presence of metabolic activation. Therefore, the substance is not considered to be genotoxic in this assay.
Other tests
Absence of genotoxicity in vitro was reported in two non-standard tests (Nakajima, 2006). One of the non-standard tests was the umu test for DNA damage and the other an in-vitro cell transformation assay. The umu assay detects genetic damage using the expression of the genes involved in SOS repair that follows the damage. In this assay, lumineseent and light absorption Umu-tests were performed. The luminescent umu-test was performed using the Salmonella typhimurium TL210 strain. The light absorption umu-lest used the S. typhimurium TA1535/pSK1002 strain, with chlorophenolred-ß-D-galactopyranoside (CPRG) as the substrate. Octabenzone did not cause signs of genetic damage in the either umu assay.
The promotion activity was examined by the Bhas assay, a method that uses Bhas 42 cells for the formation of transformation foci. Bhas 42 cells were derived from BALB/3T3 cells. A phorbol ester (TPA) was used as a positive control. It caused a tenfold increase in the number of foci at a concentration of 50 ng/ml. Octabenzone caused no increase in foci formation at concentrations up to 10 μg/ml which was the hightest concentration that could be tested.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genotoxicity under Regulation (EC) No. 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.
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.
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