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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Diphenyl carbonate
- EC Number:
- 203-005-8
- EC Name:
- Diphenyl carbonate
- Cas Number:
- 102-09-0
- Molecular formula:
- C13H10O3
- IUPAC Name:
- diphenyl carbonate
- Details on test material:
- purity 99.98 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- according to Guideline
body weight on day 0 p.c.: 207 to 249 g
age of females on day 0 p.c.: 12-16 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- vehicle: carboxymethylcellulose 0.5 % in deionized water
administration volume: 10 ml/kg bw
The dose levels used were selected according to a preceding dose-range finding study (Study No. T0062796) in rats with dose levels of 0, 20, 125, and 750 mg/kg bw/d. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Investigations on stability and homogeneity of the test compound in samples of 1 mg/ml and 100 mg/ml were performed. Stability and homogeneity were confirmed.
- Details on mating procedure:
- 1 male/2 females per cage; if sperm was detected in the vaginal smear this day was day 0 of gestation
- Duration of treatment / exposure:
- days 6 - 19 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- cesarian section and sacrifice at day 20 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 750 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- No. of females/dose: 25 (50 mg/kg and 750 mg/kg group: 28) inseminated females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
Duration of test: sacrifice on day 20 of gestation
Examinations
- Maternal examinations:
- Body weight gain: on day 0 p.c. and daily from day 6-20
Food consumption: yes
Water consumption: yes (by visual estimation)
Clinical observations: appearance, behaviour, excretory products and mortality, from day 0 -20 twice daily
Gross pathological examination: at time of cesarian section on day 20 p.c. or after death/premature sacrifice - Ovaries and uterine content:
- gravid uterine weight, no. of corpora lutea, no. of implantations, no. of resorptions, placenta weight
- Fetal examinations:
- Examination of fetuses: number, weight and sex of live fetuses, external, visceral and skeletal malformations
Total numer of live fetuses examined: 275/249/269/253 - Statistics:
- Kruskal-Wallis test, analysis of variance, Dunnett's test, Chi² test were used
- Historical control data:
- yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- only in 750 mg/kg group: signs of severe toxicity after administration (convulsions and ventral posture), which disappeared within 4 hours; in surviving females such clinical signs became less severe or were not longer evident with increasing duration of treatment; piloerection;
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- In 750 mg/kg group 5 females died (4 after 1st dose, 1 after 7th dose)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight development: stat. sign. reduced at 750 mg/kg throughout the entire study (mean body weight gain day 0-20 reduced by 24%); in the 200 mg/kg bw/day group stat. sign. reduced only on day 6-7 p.c. and remained marginally reduced up to sacrifice
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- distinctly reduced in 750 (up to 36%) and slightly reduced in 200 mg/kg group (up to 12% on days 6-12)
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- water consumption increased only in high dosed females
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Placenta weight: unaffected
- Description (incidence and severity):
- In 750 mg/kg group some females showed empty of gas filled stomach, related to morbidity/mortility and regarded as unspecific finding.
Placenta appearance: at 750 mg/kg engorged placentae/ necrotic placental borders - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Description (incidence and severity):
- Total number of females with implantations (vehicle control, 50, 200, 750 mg/kg bw/d): 23/22/25/21
No. of resorptions: 0/0/1/0
Total number of females with viable fetuses: 23/22/24/21
No. of corpora lutea/female: 14.3/14.3/14.9/14.7
Postimplantation loss/female: no meaningful effects (0.7/0.8/1.1/1.2) since no. of viable fetuses per litter not affected and inbetween historical control range
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: yes
Details on embryotoxic / teratogenic effects:
see Remarks on results
For selected fetuses a peer review of fetal visceral findings was performed by Tesh Consultants International, UK.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No. of viable fetuses: 275/249/269/253
No. of dead fetuses: 0/0/2/1 (deaths did not affect the mean number of viable fetuses per litter and was comparable to the incidences in historical control, so that toxicological relevance was not assumed)
Sex ratio (% males): not affected (48.4/50.1/50.5/48.6)
Fetal weight (mean in g): 3.77/3.74/3.64/3.40 (high dose group p<0.01)
Fetal malformations: at 750 mg/kg bw (severe maternally toxic dose) incidence of common malformations increased on a fetal and litter basis as
- dysplastic forelimb bones: fetal incidence 5.5%, litter incidence 33.3% compared to 0% in control (in historical control groups indicences of up to 4.3/20% were seen)
- 2 cases of multiple malformations
- 3 cases of atrial septal defect of the heart within 3 litters
- 2 cases of flat and stretched kidneys
- 1 case of situs inversus
- 1 case of shortened tail with missing sacral and caudal vertebrae
Fetal external and visceral deviations: no TS-related effects
Fetal skeletal deviations including cartilaginous deviations: slightly retarded ossification in comparison to control could not be completely excluded in the 200 mg/kg group (retarded ossification of distal phalanges of toes, cervical vertebral bodies, sacral vertebral arches and wavy ribs: only stat. sign. when calculated on a fetal basis) and was evident to a more pronounced degree in the 750 mg/kg group.
Fetal cartilage was not affected. The overall number and type of malformations were not increased at a dose level up to and including 200 mg/kg bw/day.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the NOAEL for maternal toxicity and developmental toxicity in rats was 50 mg/kg bw/day. At 200 mg/kg bw/day slight maternal toxicity occurred and a retarding effect on foetal skeletal ossification of toes and cervical vertebral bodies could not be completely excluded.
- Executive summary:
The developmental toxicity of the substance was investigated in a study which was conducted in accordance with the standardised guideline OECD 414 under GLP conditions.
During the study test material was administered to rats once daily via oral gavage at dose levels of 50, 200 and 750 mg/kg bw to 25 females per dose. The vehicle was 0.5 % carboxymethylcellulose in deionised water and the dose volume was 10 mL/kg bw. Maternal animals were dosed on days 6 - 19 of gestation and underwent caesarean section and sacrifice on day 20 of gestation.
Administration of 750 mg/kg bw/day led to severe maternal toxicity (mortality, convulsions, piloerection, body weight loss). Foetuses of this dose group showed reduced body weights and increased incidences of unspecific malformations (mainly dysplastic forelimb bones).
No effects were observed on the number of females with implantations, number of resorptions, total number of females with viable foetuses, the number of corpora lutea per female, post implantation loss or placenta weight. At 750 mg/kg bw/day, placentae appeared to be engorged with necrotic placental borders.
The number of dead foetuses did not affect the mean number of viable foetuses per litter and was comparable to the incidences in historical control, so that toxicological relevance was not assumed.
The sex ratio of offspring was not affected by treatment. The foetal weight in the high dose group was statistically significantly reduced.
Foetal malformations were observed at 750 mg/kg bw (severe maternally toxic dose); the incidence of common malformations increased on a foetal and litter basis: dysplastic forelimb bones (foetal incidence 5.5 %, litter incidence 33.3 % compared to 0 % in control, though in historical control groups incidences of up to 4.3/20 % were seen); 2 cases of multiple malformations; 3 cases of atrial septal defect of the heart within 3 litters; 2 cases of flat and stretched kidneys; 1 case of situs inversus; and 1 case of shortened tail with missing sacral and caudal vertebrae.
There were no test material-related effects on foetal external and visceral deviations. The following foetal skeletal deviations (including cartilaginous deviations) were seen: slightly retarded ossification in comparison to control could not be completely excluded in the 200 mg/kg group (retarded ossification of distal phalanges of toes, cervical vertebral bodies, sacral vertebral arches and wavy ribs; this was only statistically significant when calculated on a foetal basis) and was evident to a more pronounced degree in the 750 mg/kg group. Foetal cartilage was not affected. The overall number and type of malformations were not increased at a dose level up to and including 200 mg/kg bw/day.
Under the conditions of this study, the NOAEL for maternal toxicity and developmental toxicity in rats was 50 mg/kg bw/day. At 200 mg/kg bw/day slight maternal toxicity occurred and a retarding effect on foetal skeletal ossification of toes and cervical vertebral bodies could not be completely excluded.
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