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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
Endpoint summary
Administrative data
Description of key information
ORAL
LD50 1500 mg/kg bw , rat (male/female), OECD 401, FitzGerald (1990)
DERMAL
LD50 >2000 mg/kg bw, rat (male/female), OECD 402, Krötlinger (1999)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, MA
- Age at study initiation: 32-68 days
- Weight at study initiation: 100-225 grams
- Fasting period before study: over night
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: no data
DOSAGE PREPARATION (if unusual): Test substance was ground to a find powder and suspended in corn oil (heated to 45°C). The suspension was cooled to 37°C for dosing. - Doses:
- 750, 1500 and 3000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The method of Litchfield and Wilcoxon could not be employed due to a limitation in this procedure that requires at least two response values that are not 0 or 100 %.
- Preliminary study:
- Limit study: 5/sex; dose: 5000 mg/kg bw; mortality: 7 of 10 animals died
Range Finding study: 1/sex/dose; doses: 500, 1000, 1500, 2000, 4000 mg/kg bw - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 500 mg/kg bw
- Mortality:
- 3000 mg/kg: all animals died by the end of day 1
1500 mg/kg: two out of the ten animals (1m/1f) died by 4 h and 3 died (1m/2f) by day 1 of the study. Five animals survived the 14 day observation period
750 mg/kg: all animals survived at this dose level - Clinical signs:
- other: 3000 mg/kg: the one animal that survived until day 1 showed signs of clonic convulsions 1500 mg/kg: the five surviving animals and three of the animals that died experienced clonic convulsions 750 mg/kg: none of the surviving animals exhibited any cli
- Gross pathology:
- no unusual lesions were noted in any of the animals
- Interpretation of results:
- other: Acute category 4 according to EU criteria
- Conclusions:
- The LD50 of the test substance has been determined to be 1500 mg/kg bw based upon the observed 50 % mortality at this dose.
- Executive summary:
The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guideline OECD 401, under GLP conditions.
During the study Sprague-Dawley male and female rats (five animals per sex per dose) were dosed with the test material in corn oil via gavage at 750, 1500 and 3000 mg/kw bw and observed over a 14 day period.
Under the conditions of this study, the acute oral LD50 of Diphenyl carbonate in rats was determined to be 1500 mg/kg bw, with clonic convulsions the main clinical sign appearing at doses near to or exceeding the LD50 value.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 500 mg/kg bw
- Quality of whole database:
- The quality of the whole database is considered to be good. The key study was performed in accordance with a standardised guideline under GLP conditions. There are a further six supporting studies available, all with limited documentation, and thus all awarded a reliability score of 2 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- modified according to the acute toxic class method
- GLP compliance:
- yes
- Remarks:
- Deviation from GLP: No analytical investigations on stability and homogeneity were perfomed.
- Test type:
- other: acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: mean 273 g for males and 216 g for females
- Fasting period before study: none
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- For a better contact to the skin, the test substance was moistened with water, applied to the prepared skin area and fixed with non-irritant skin plaster (occlusive conditions) for 24 hours.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Deviation from OECD 402: the number of animals and the procedure of dose finding was done according to OECD guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method) due to animal welfare reasons.
- Statistics:
- none: limit test
- Preliminary study:
- none
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no noticable gross pathological findings
- Other findings:
- no local effects
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the acute dermal LD50 in rats was determined to be greater than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the substance was investigated in accordance with the standardised guideline OECD 402 modified according to the acute toxic class method under GLP conditions.
During the study three male and three female Wistar rats were exposed to the test material moistened with water at a limit dose of 2000 mg/kg in an occlusive fashion for 24 hours.
Under the conditions of this study, the acute dermal LD50 in rats was determined to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The quality of the whole database is considered to be good. The key study and one supporting study were performed in accordance with a standardised guideline under GLP conditions. There is a further supporting study available, with limited documentation, awarded a reliability score of 2 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).
Additional information
Oral
This endpoint is addressed with seven studies; one key study and six supporting studies. The key study was awarded a reliability score of 1 and the supporting studies were all awarded a reliability score of 2 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997) due in part to limited documentation.
The key study (FitzGerald, 1990) is a GLP compliant study performed in accordance with the standardised guideline OECD 401.
Sprague-Dawley male and female rats (five animals per sex per dose) were dosed with the test material in corn oil via gavage at 750, 1500 and 3000 mg/kw bw and observed over a 14 day period. Under the conditions of this study, the acute oral LD50 of Diphenyl carbonate in rats was determined to be 1500 mg/kg bw, with clonic convulsions the main clinical sign appearing at doses near to or exceeding the LD50 value.
In the first supporting study (Kimmerle, 1967) (rat), fifteen animals were used per sex per dose, with male animals being dosed at 500, 1000 and 2500 mg/kg bw and female animals being dosed at 1000 and 2500 mg/kg bw. The vehicle used for the administration of the test material was water and Cremophor EL. The test material was administered at concentrations of 5, 10 and 25 % at the 500, 1000 and 2500 mg/kg dose levels, respectively. Animals were observed for seven days.
Under the conditions of this study, the acute oral toxicity in both male and female rats was determined to be >2500 mg/kg bw.
In the second supporting study (Kimmerle, 1967) (mouse), male animals were dosed at 250, 500 and 1000 mg/kg bw with the test material in water and Cremophor EL (15 animals per dose). Animals were then observed over a seven day period.
Under the conditions of this study, the LD50 was determined to be >1000 mg/kg bw.
In the third supporting study (Kimmerle, 1967) (dog), animals were dosed at 250, 500 and 1000 mg/kg bw with the test material in water and Cremophor EL (one or two animals per dose level) and observed over a seven day period.
Under the conditions of this study, the LD50 was determined to be>1000 mg/kg bw.
In the fourth supporting study (Kimmerle, 1963) (rat), male animals were exposed to the test material at dose levels of 100, 250, 500, 1000 and 2500 mg/kg bw in DMSO with 10 animals per dose.
Under the conditions of this study, the LD50 was determined to be >2500 mg/kg.
In the fifth supporting study (Kimmerle, 1963) (guinea pig), females were exposed to the test material at dose levels of 500 and 1000 mg/kg bw in water and Cremophor EL (five animals per dose level). Animals were then observed over a seven day period.
Under the conditions of this study, the LD50 was determined to be>1000 mg/kg bw.
In the final supporting study (Kimmerle, 1967) (rabbit), animals were dosed at either 500 or 1000 mg/kg bw test material with water and Cremophor EL (three rabbits per dose level). Animals were then observed over a seven day period.
Under the conditions of this study, the LD50 was determined to be>1000 mg/kg bw.
Inhalation
In accordance with Section 8.5.2 of Column 2 of REACH Annex VIII, it is considered justified to omit acute toxicity testing by the inhalation route on the grounds that exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Dermal
This endpoint is addressed with three studies; one key study and two supporting studies.
The key study (Krötlinger, 1999) was performed in accordance with the standardised guideline OECD 402 modified according to the acute toxic class method under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).
Three male and three female Wistar rats were exposed to the test material moistened with water at a limit dose of 2000 mg/kg in an occlusive fashion for 24 hours.
Under the conditions of this study, the acute dermal LD50 in rats was determined to be greater than 2000 mg/kg bw.
In the first supporting study (Desai, 1990a) the acute dermal toxicity potential of diphenyl carbonate was determined in study that was performed in accordance with the standardised guideline OECD 402 under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Male and female New Zealand White rabbits (5/sex/dose) were exposed to the test material moistened with water at a limit dose of 2000 mg/kg in an occlusive fashion for 24 hours. Animals were observed immediately following dosing and three times during the first two hours after application. Animals were observed twice daily for 14 days for clinical manifestations and mortality.
Under the conditions of this study, the acute dermal LD50 was determined to be greater than 2000 mg/kg bw.
In the second supporting study (Kimmerle, 1967), the acute dermal toxicity potential of diphenyl carbonate to rats was determined in study that was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997) as there is limited documentation.
Male rats were exposed to the test material at a dose of 500 mg/kg (prepared as a 10 % emulsion). The test material was not removed and the animals were observed for 7 days.
Under the conditions of the study, the acute dermal LD50 in male rats was determined to be greater than 500 mg/kg bw.
Other Routes
There are two studies available to address the acute toxicity of diphenyl carbonate via the intraperitoneal route. Both 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.
The first study (Kimmerle, 1963) was performed using ten (presumably male) rats per dose. The animals were dosed at 0.005, 0.01, 0.025, 0.05, 0.1, 0.25, 0.5 and 1 g/kg bw in DMSO. Animals were observed for 7 days.
Under the conditions of this study, the LD50 was determined to be 200 mg/kg.
The second study ( Kimmerle, 1967) was performed in male rats. Fifteen animals per dose were treated at 100, 250, 500, 750, 1000, 1500, 2000 and 2500 mg/kg bw using water and Cremophor EL as the vehicle. Clinical symptoms observed included convulsions and bad condition starting 10 to 20 minutes and up to 3 days after dosing. Deaths occurred in the first 24 hours after dosing.
Under the conditions of the study, the LD50 was determined to be 1005 mg/kg.
Justification for selection of acute toxicity – oral endpoint
Although there are a number of studies available to address this endpoint, the key study was selected on the basis that it was conducted in a standard species and was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997). The remaining studies were judged to be more appropriate as supporting data.
Justification for selection of acute toxicity – dermal endpoint
There are a number of studies available to address this endpoint; the key study was selected on the basis that it was conducted in the species most commonly used to address this endpoint (rat) and was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997). The remaining studies were judged to be more appropriate as supporting data.
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 acute toxicity via the dermal route.
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance requires classification with respect to acute toxicity via the oral route as Category 4 (H302: Harmful if swallowed).
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