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EC number: 946-383-6 | CAS number: -
- 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
Reaction mass of Carbamic acid, N-(5-isocyanato-2-methylphenyl)-, 2-ethylhexyl ester and Carbamic acid, N-(3-isocyanato-4-methylphenyl)-, 2-ethylhexyl ester and N,N'-(4-Methyl-1,3-phenylene)bis(carbamic acid) C,C'-bis(2-ethylhexyl) ester (EC: 937-955-6) Read-across data:
Acute toxicity: oral - LD50 was >5.0 mL/kg.
Acute toxicity: dermal - LD50 > 2.0 mL/kg; undiluted
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to a recognised guideline in accordance with generally accepted scientific principles.
- Qualifier:
- according to guideline
- Guideline:
- other: Standard (FHSA) Procedures.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Weight range at initiation was 197 - 252 grams.
- Fasting period before study: fasted for 16 hours.
- Diet (e.g. ad libitum): Wayne diet ad libitum.
- Water (e.g. ad libitum): ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Not specified
- Doses:
- A single dose of 5.0 mL/kg.
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- Not specified
- Statistics:
- LD50 was calculated by probit transformation based on 14 days of observation.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality
- Clinical signs:
- other: Yellow mucoid diarrhoea was observed in seven of the ten animals 3 h after dosing. All animals appeared normal for the remainder of the study.
- Gross pathology:
- Gross necropsy revealed a dilated pelvis of the right kidney in one male rat, but this was not considered to be related to the material dosed.
- Other findings:
- No other findings specified.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 was >5.0 mL/kg (dosed undiluted).
- Executive summary:
The test material was administered undiluted to 10 fasted Wistar rats as a single oral gavage dose of 5.0 mL/kg.
Yellow mucoid diarrhoea was seen in all the male animals and two females 3 hours after dosing. No other clinical signs were observed and no mortality occurred.
The LD50 was therefore >5.0 mL/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- K2 - only study available.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to a recognised guideline in accordance with generally accepted scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: I.R.L.G. Guidelines method
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- Two rabbits per sex were dosed on the dorsal area (240 cm2) abraded and dosed at 2.0 mL/kg undiluted material. Covered with porous gauze dressing and a semi-occlusive wrapping of polyethylene. Rabbits restrained in hood facing outward for 24-hour contact period to avoid their inhaling any volatiles. The IRLG guidelines recommend a semi-occlusive sheeting and no immobilisation during the contact period.
The animals were observed for 14 days. - GLP compliance:
- not specified
- Test type:
- other:
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet (e.g. ad libitum): Appropriate Wayne diet ad libitum.
- Water (e.g. ad libitum): ad libitum. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 240cm^2
- Type of wrap if used: porous gauze dressing covered by a semi occlusive polyethylene wrapping
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2mL/kg
VEHICLE
N/A - Duration of exposure:
- 24 hours.
- Doses:
- 2.0 mL/kg.
- No. of animals per sex per dose:
- 2 animals per sex per dose.
- Control animals:
- no
- Details on study design:
- Dorsal area (240 cm2) abraded and dosed at 2.0 mL/kg undiluted material. Covered with porous gauze dressing and a semi-occlusive wrapping of polyethylene. Rabbits restrained in hood facing outward for 24-hour contact period to avoid their inhaling any volatiles.
The animals were observed for 14 days.
LD50 was calculated by probit transformation based on 14 days of observation.
Observations were made during this time to assess skin reactions and bodyweight changes.
At the end of the observation period, animals were necropsied. - Statistics:
- Not reported
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95%CL not reported
- Mortality:
- No deaths occured during the study.
- Clinical signs:
- other: Skin damage caused by the manipulative trauma of removing the gauze and sheeting at 24 hours. Scabbing over of skin injuries at 48 hours. Soft stool noted on various days throughout the 14-day observation period.
- Gross pathology:
- Rough edges on liver (2 females); spleen injected (1 female); upper right lung lobe dark red after washing (1 male)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD 50 of the substance was determined to be >2.0 mL/kg; undiluted.
- Executive summary:
The skin penetration of the test material was investigated in a single dose in accordance with Modified I.R.L.G. Guidelines method. (1979).
Two rabbits per sex dosed on abraded skin at 2.0 mL/kg of the undiluted material had moderate to marked capillary injection as a result of the 24-hour application under semi-occlusive polyethylene sheeting. At the end of the 14-day observation period, all animals had gained weight. No mortality was seen.
LD50 > 2.0 mL/kg; undiluted
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K2 - only study available
Additional information
Acute toxicity: oral
The test material was administered undiluted to 10 fasted Wistar rats as a single oral gavage dose of 5.0 mL/kg.
Yellow mucoid diarrhoea was seen in all the male animals and two females 3 hours after dosing. No other clinical signs were observed and no mortality occurred.
The LD50 was therefore >5.0 mL/kg (5000 mg/kg bw).
Acute toxicity: dermal
Two rabbits per sex dosed on abraded skin at 2.0 mL/kg of the undiluted material had moderate to marked capillary injection as a result of the 24-hour application under semi-occlusive polyethylene sheeting. At the end of the 14-day observation period, all animals had gained weight. No mortality was seen.
LD50 > 2.0 mL/kg; undiluted (2000 mg/kg bw).
Justification for classification or non-classification
According to Regulation (EC) 1272/2008 table 3.1.1, the test substance does not require classifying as acutely toxic via the oral or dermal route based on the data obtained from the read-across substance.
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