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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 214-540-1 | CAS number: 1143-72-2
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Dec 1987 - 06 Jan 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- (2 sampling times instead of the recommended 3; 50 metaphases counted while 200 is recommended; the cell cycle length not given; 500 cells scored for MI while 1000 is recommended; no cytotoxicity observed in bone marrow based on MI)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Version / remarks:
- adopted Jul 2016
- Deviations:
- yes
- Remarks:
- (2 sampling times instead of the recommended 3; 50 metaphases counted while 200 is recommended; the cell cycle length not given; 500 cells scored for MI while 1000 is recommended; no cytotoxicity observed in bone marrow based on MI)
- GLP compliance:
- yes
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Reference substance name:
- 2,3,4-trihydroxybenzophenone
- EC Number:
- 214-540-1
- EC Name:
- 2,3,4-trihydroxybenzophenone
- Cas Number:
- 1143-72-2
- Molecular formula:
- C13H10O4
- IUPAC Name:
- 4-benzoylbenzene-1,2,3-triol
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: Chinese hamster inbred strain
- Details on species / strain selection:
- The Chinese hamster is an animal which has been used for many years as suitable experimental animal in cytogenetic investigations. This species, although little used in other aspects of toxicology, has a karyotype with 22 chromosomes all of which are easily identified. This offers the opportunity to reduce observer errors and the time required for the cytogenetic analysis.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LMP stock
- Age at study initiation: Minimum 10 weeks
- Weight at study initiation: Approximately 25 g
- Fasting period before study: Yes, animals received no food approximately 18 h beore treatmen with the test substance.
- Housing: The animals were individually housed in Makrolon Type I cages with wire mesh top (EBECO, Castrop-Rauxel, Germany) on granulated soft wood bedding (Altromin, Lage/Lippe, Germany).
- Diet: Pelleted standard diet (Altromin, Lage/Lippe, Germany)
- Water: Tap water, ad libitum
- Acclimation period: Minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Methocel MC
- Justification for choice of solvent/vehicle: The vehicle was chosen to its relative nontoxicity for the animals.
- Amount of vehicle: 20 mL/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: On the day of the experiment, the test substance was suspended in 0.5 % Methocel solution. All animals received a single standard dose volume adjusted to the body weight orally.
- Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- single treatment
- Post exposure period:
- 24 and 48 h after treatment
Doses / concentrations
- Dose / conc.:
- 4 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: oral
- Doses / concentrations: 30 mg/kg bw in physiological saline
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: A range finding study was performed to find the maximum tolerated dose of the test substance based on mortality. In the first pre-experiment 2 males and 2 females were treated with 5000 mg/kg bw. In the second pre-experiment 10 males were exposed to 5000 mg/kg bw and in the third pre-experiment 2 males and 2 females received 4000 mg/kg bw.
DETAILS OF SLIDE PREPARATION: Following treatment and prior to sample collection, animals were injected intraperitoneally with 2 mg/mL Colcemid®, and samples were collected 2.5 hours thereafter. Cells were harvested from the bone marrow, swollen, fixed and stained, and analysed for chromosomal aberrations.
METHOD OF ANALYSIS: At least 50 well spread metaphases were analysed per animal by use of NIKON microscopes with 100x oil immersion objectives and were scored for structural chromosome aberrations (gaps, breaks, fragments, deletions, exchanges and chromosomal disintegrations). - Evaluation criteria:
- The test article is classified as mutagenic if it induces a significantly increased aberration rate with at least one of the concentrations tested as compared with the negative control.
This can be confirmed by means of the nonparametric Mann-Whitney test. A test article which produces no significant positive response at any test point is regarded as non-mutagenic in this assay. - Statistics:
- Statistical analysis was not performed due to the obtained results.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 4000 and 5000 mg/kg bw
- Solubility: Suspension in 0.5% Methocel solution
- Clinical signs of toxicity in test animals: Reduction of spontaneous activity, apathy and abdominal position were observed in both dose groups. 1/2 males of the first pre-experiment and 5/10 males of the second pre-experiment died at 5000 mg/kg bw. None of the exposed animals died at 4000 mg/kg bw.
Any other information on results incl. tables
Table 1: Summary of results
Dose (mg/kg bw) | Postexposure period [h] | Number of cells scored | Aberrant cells incl. gaps (%) | Aberrant cells excl. gaps (%) | Mitotic index (%) |
4000 | 24 | 500 | 0.6 | 0.0 | 5.50 |
4000 | 48 | 500 | 2.2 | 0.4 | 6.51 |
Negative control | 24 | 500 | 2.4 | 1.2 | 5.60 |
Positive control | 24 | 500 | 13.4 | 9.8 | 5.28 |
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.
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.