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EC number: 203-005-8 | CAS number: 102-09-0
- 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
Carcinogenicity
Administrative data
Description of key information
Old and limited studies in B6C3F1 and B6AKF1 mice with oral dosing (3 weeks oral gavage followed by oral feeding) of 100 mg/kg bw/day diphenyl carbonate for 18 months showed no increase in tumor incidences (Bionetics, 1968).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Of the four supporting studies, two were awarded a reliability score of 2 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997) and two were awarded a reliability score of 3. The overall quality of the database is therefore considered to be adequate.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to carcinogenicity.
Additional information
In accordance with Section 8.9.1 of Column 2 of REACH Annex X, it is considered justified to omit the carcinogenicity study on the grounds that the substance does not have a widespread dispersive use and there is no evidence of frequent or long-term human exposure. Furthermore, the substance has shown no evidence of potential to cause germ cell mutagenicity nor is there evidence from the repeated dose study that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
Supporting Information
There are four supporting study summaries to address this endpoint. The work was carried out prior to the inception of GLP and no guidelines were followed. Two were awarded a reliability score of 2 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997), as there is limited documentation. Two were awarded a reliability score of 3 due to an unsuitable test system. All 4 were summarised from the same report (Bionetics, 1968).
The first and second supporting study summaries were both performed in male and female mice; the first endpoint summarises the effects in (C57BL/6 X AKR)F1 mice and the second summarises the effects in (C57BL/6 X C3H/Anf)F1 mice. Identical methodology was used for both strains and identical results were obtained.
A carcinogenicity study was carried out with 130 chemicals and 7 positive controls. The test material was administered at 100 mg/kg (18 animals per sex) via gavage in 0.5 % gelatin for the first 3 weeks of the study, followed by oral feeding. The test material was mixed directly with the diet, which was provided ad libitum. The same concentration (approximately the maximal tolerated dose) was maintained throughout the 18 month administration period. Administration of the test material began when the mice were 7 days of age.
The postmortem procedure included an external examination and a thorough examination of thoracic and abdominal cavities, with histologic examination of major organs and of all grossly visible lesions. Mortality-related observations included no treatment related differences; tumour incidences were not affected by the test material (only limited information). Necropsy findings included no significant findings as compared to untreated and vehicle controls whereas clinical signs observed were not reported. The administration of the positive control substances resulted in the expected increases in tumour incidence.
The third and fourth supporting study summaries were both performed in male and female mice; the third endpoint summarises the effects in (C57BL/6 X C3H/Anf)F1 mice and the fourth summarises the effects in (C57BL/6 X AKR)F1 mice. Identical methodology was used for both strains and identical results were obtained.
A carcinogenicity study was carried out with 130 chemicals. The test material was administered as a single subcutaneous injection into the nape of the neck of 18 animals per sex at a dose of 1000 mg/kg when the animals were 28 days of age. The test material was dosed as a suspension in DMSO at an application volume of 0.05 mL. The MTD was determined in a preliminary acute toxicity study. The animals were observed for 18 months.
No treatment related differences were observed; tumour incidences were not affected by the test material, however, there is only limited information available.
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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