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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
SKIN
Not irritating, rabbit, OECD 404, Desai (1990)
EYE
Not irritating, rabbit, OECD 405, Desai (1990b)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent area of untreated skin on each animal served as the control
- Amount / concentration applied:
- Concentration: 100 %
Test substance was ground to a fine powder and a dose of 0.5g was applied to each application site - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 30-60 min, 24h, 48h, and 72h after the 4 hour exposure period
- Number of animals:
- 6 females
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, and 72h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- none
- Other effects:
- none
- Interpretation of results:
- other: Not irritating according to EU criteria
- Conclusions:
- Under the conditions of this study, diphenyl carbonate is considered to be a non-irritant.
- Executive summary:
The skin irritation potential of the substance was investigated in a study which was conducted in accordance with the standardised guideline OECD 404 under GLP conditions.
During the study six (female) New Zealand White rabbits were dosed with 0.5 g of the test material in a semi-occlusive fashion for four hours. Observations were made at 30 to 60 minutes, 24, 48 and 72 hours after the end of the contact period. No erythema/oedema was observed for any animal at any time period.
Under the conditions of this study, diphenyl carbonate is considered to be a non-irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- females
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated, and thus served as a control
- Amount / concentration applied:
- Concentration: 100 %
The test substance was ground to a fine powder and a dose of 0.1 grams was administered to the left eye of each animal. - Duration of treatment / exposure:
- The eyes of the test animals were not washed out for 24 hours following instillation.
- Observation period (in vivo):
- Eyes were examined at 1, 24, 48, and 72 hours after treatment using the Draize scale.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Fluorescein staining was used during each examination, excluding the 1 hour examination.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, and 72 hours
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: the first 24 hours after treatment
- Remarks on result:
- other: Slight swelling (Grade 1) of conjunctivae was evident in the treated eyes of the test animals at 1 hour (5/6 animals) only. No signs of irritation were evident at the 24, 48, or 72 hour observation points, therefore the study was not continued
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- none
- Interpretation of results:
- other: Not irritating according to EU criteria
- Conclusions:
- Under the conditions of this study, diphenyl carbonate is not irritating to the eyes of rabbits.
- Executive summary:
The eye irritation potential of the substance was investigated in a study which was conducted in accordance with the standardised guideline OECD 405 under GLP conditions.
The test material was ground to a fine powder and a dose of 0.1 grams was administered into the left eye of six female New Zealand White rabbits. The eyes were examined at 1, 24, 48, and 72 hours after treatment using the Draize scale. Slight swelling (Grade 1) of conjunctivae was evident in the treated eyes of the test animals at 1 hour (5/6 animals) only. No signs of irritation were evident at the 24, 48, or 72 hour observation points.
Under the conditions of this study, diphenyl carbonate is not irritating to the eyes of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
The skin irritation potential of diphenyl carbonate is addressed with two studies.
The key study (Desai, 1990) was conducted in accordance with the standardised guideline OECD 404 under GLP conditions. It was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).
Six (female) New Zealand White rabbits were dosed with 0.5 g of the test material in a semi-occlusive fashion for four hours. Observations were made at 30 to 60 minutes, 24, 48 and 72 hours after the end of the contact period. No erythema/oedema was observed for any animal at any time period.
Under the conditions of this study, diphenyl carbonate is considered to be a non-irritant.
The supporting study (Kimmerle, 1963) was awarded a reliability score of 3 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997). The test appears to have significant methodological deficiencies but only limited data is available.
The test was performed using one rabbit; the solid was moistened with water (left ear) or oil (right ear) and applied to the external ear on a gauze patch. The gauze patch was fixed with a tape during the exposure period (24 h). The animals were observed for 7 days. Immediately after the patch was removed slight erythema and oedema was observed at both ears. At the right ear these signs of irritation lasted for 24 hours and disappeared after 48 hours.
Under the conditions of this study, slight signs of irritation were observed.
Eye Irritation
The eye irritation potential of diphenyl carbonate is addressed with two studies.
The key study (Desai, 1990b) was conducted in accordance with the standardised guideline OECD 405 under GLP conditions. It 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 test material was ground to a fine powder and a dose of 0.1 grams was administered into the left eye of six female New Zealand White rabbits. The eyes were examined at 1, 24, 48, and 72 hours after treatment using the Draize scale. Slight swelling (Grade 1) of conjunctivae was evident in the treated eyes of the test animals at 1 hour (5/6 animals) only. No signs of irritation were evident at the 24, 48, or 72 hour observation points.
Under the conditions of this study, diphenyl carbonate is not irritating to the eyes of rabbits.
The supporting study (Kimmerle, 1963) was awarded a reliability score of 4 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).
The species used for this test was the rabbit. The test material was placed in the conjunctival sac. After 1 hour the eye was washed out with water. No irritation of the conjunctivae and no corneal lesions were observed.
Under the conditions of this study, diphenyl carbonate is considered to be not irritating.
Respiratory Irritation
No data are available with regard to respiratory tract irritation. Based on the toxicological data available for other routes, it is not considered to be likely that the substance will cause irritation to the respiratory tract.
Justification for selection of skin irritation / corrosion endpoint:
The key study was selected on the basis that it was performed in accordance with a standard guideline under GLP conditions. It was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).
Justification for selection of eye irritation endpoint:
The key study was selected on the basis that it was performed in accordance with a standard guideline under GLP conditions. It was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997)..
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 skin or eye irritation.
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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