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EC number: 205-503-0 | CAS number: 141-82-2
- 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: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- GST-P foci assay following diethyl nitrosamine exposure.
Data source
Reference
- Reference Type:
- publication
- Title:
- Enhancing effect of various hepatocarcinogens on induction of preneoplastic glutathione S-transferase placental form positive foci in rats—an approach for a new medium-term bioassay system
- Author:
- Ito, N.; et al
- Year:
- 1 988
- Bibliographic source:
- Carcinogenesis, 9(3) 1, 387–394,
Materials and methods
- Principles of method if other than guideline:
- The animals in each experiment were divided into three groups. Group 1 was given a single i.p. injection of DEN (200 mg/kg) dissolved in 0.9% NaCl to initiate hepatocarcinogenesis. After 2 weeks on basal diet, they received one of the test compounds in the basal diet (D), drinking water (W), by i.p. or i.v. injection. Animals were subjected to PH at week 3 to maximize any interaction between proliferation and the effects of the compounds tested. Group 2 was given DEN and PH in the same manner as for group 1 without administration of any test compounds. Group 3 animals were injected with 0.9% NaCl instead of DEN solution and then subjected to administration of test compound and PH.Rats in each group were killed for examination at week 8.The doses of test compounds were chosen on the basis of preliminary investigations as permitting >70% survival of rats after PH performed during the administration, or from chronic toxicity data when available.
- GLP compliance:
- not specified
- Type of assay:
- other: induction of glutathione S-transferase placental formpositive (GST-P+) foci in the liver
Test material
- Reference substance name:
- Malonic acid
- EC Number:
- 205-503-0
- EC Name:
- Malonic acid
- Cas Number:
- 141-82-2
- Molecular formula:
- C3H4O4
- IUPAC Name:
- propanedioic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Batch No: 20160723Purity: 99.5 %
Constituent 1
- Specific details on test material used for the study:
- Source: Tokyo Chemical Industry Co., Ltd., Tokyo, Japan
Test animals
- Species:
- rat
- Strain:
- other: Fischer
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Source: Charles River Japan Inc., Atsugi, Japan - Weight at study initiation: — 160 g - Housing: Plastic cages - Diet: (Oriental M, Oriental Yeast Co., Tokyo) ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 24C Animals were housed in an air-conditioned room
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- 400 mg/kg/day exposure for 6 weeks via diet
Doses / concentrations
- Dose / conc.:
- 4 000 ppm
- No. of animals per sex per dose:
- 17
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The study was an an assay of 112 compounds, including a number of known carcinogens.
Examinations
- Tissues and cell types examined:
- Liver
- Details of tissue and slide preparation:
- Immediately upon killing, the liver was excised and slices were fixed for immunohistochemical examination of GST-P. Additional sections were fixed for routine staining with H & E. Sections were exposed to anti GST-P and stained for microscopic examination. As a negative control for the specificity of anti-GST-P antibody binding, preimmune rabbit serum was used instead of antiserum.The numbers and areas of GST-P+ foci or areas of > 0.2 mm in diameter were measured uand the results were assessed by comparing the values of foci between group 1 (DEN-test compounds) and group 2 (DEN alone). Group 3 served for the assay of potential to induce GST-P+ foci without prior DEN.
- Statistics:
- Statistical analysis was carried out using the Student's /-test. Scoring of the results were made on the basis of the difference of P-values between groups 1 and 2: positive, increase at P < 0.05 in either number or area of foci.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
Any other information on results incl. tables
GST-P+ foci |
|||||
DEN – test compound |
DEN alone (control) |
||||
No rats |
No/ cm2 |
Area (mm2)/cm2 |
No rats |
No/ cm2 |
Area (mm2)/cm2 |
17 |
12.33±3.81 |
1.04±0.04 |
17 |
9.09± 2.05 |
0.77±0.19 |
Statistically increased (compared to control group at P<0.01
Applicant's summary and conclusion
- Conclusions:
- In a study to develop a bioassay for screening potential liver carcinogens, based on the twostep concept of hepatocarcinogenesis, 112 different substances were screened. Carcinogenic potential was scored by comparing the number and area per cm2 of induced glutathione S-transferase placental formpositive (GST-P+) foci in the liver with those of the corresponding control group given DEN alone. Positive was scored for a significant increase in the value of GST-P+ foci, negative for no change or a decrease. Results were compared to reported Salmonella/microsome and long-term carcinogenicity test findings.
- Executive summary:
In a study to develop a bioassay for screening potential liver carcinogens, based on the twostep concept of hepatocarcinogenesis, 112 different substances were screened. Carcinogenic potential was scored by comparing the number and area per cm2 of induced glutathione S-transferase placental formpositive (GST-P+) foci in the liver with those of the corresponding control group given DEN alone. Positive was scored for a significant increase in the value of GST-P+ foci, negative for no change or a decrease. Results were compared to reported Salmonella/microsome and long-term carcinogenicity test findings.
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