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EC number: 812-963-1 | CAS number: 178436-06-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-02-05 to 1992-02-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted February 24, 1987.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- September 1984
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ceramide III
- IUPAC Name:
- Ceramide III
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Ceramide III
Constituent 1
- Specific details on test material used for the study:
- The formulations were prepared immediately prior to dosing. The test substance was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added. Adjustment was made for specific gravity of vehicle. Homogeneity of the test substance in vehicle was obtained using a homogeniser and a spatula.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: Male= 198 to 209 g, female= 150 to 164 g
- Fasting period before study: yes, feed was withheld overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Collection caging in polycarbonate cages / max. 5 rats
- Diet (e.g. ad libitum): laboratory animal diet (KLIB 343 from Klingentalmühle AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 55 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours daily
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- Dose volume: 10 mL/kg bw
DOSAGE PREPARATION: 5000 mg/kg bw were achieved by administration of two times 2500 mg/kg bw - Doses:
- 5000 mg/kg bw, given as 2 dosages of 2500 mg/kg bw within 24 hours. Multiple dosages given within 24 hours are regarded as a single dose.
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
mortality: twice daily
clinical signs: 0, 2, 4 h, daily thereafter
- Frequency of weighing: Days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- -Pilot study with three groups, each comprising of 1 male and 1 female rat
-orally dosed with test material in propylene glycol at 5000 (2x2500 within 24 hours), 2000 or 1000 mg/kg body weight
- no animal died.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Signs of ill health or behavioural changes included ataxia only observed in all animals approximately 2 hours after each dosing.
- Gross pathology:
- Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities that were not commonly noted among rats of this age and strain or that were considered toxicologically significant. Pelvic dilation (left and right kidney) in a single female rat was considered not to be related to the treatment.
- Other findings:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this acute oral toxicity study, the oral LD50 value of the test item in rats of either sex was exceeding 5000 mg/kg bodyweight.
- Executive summary:
In an acute oral toxicity study according to OECD guideline 401 (adopted February 24, 1987) and EU Method B.1 (September 1984), 5 male and 5 female, fasted, 8-9 weeks old Wistar strain rats were given a single oral dose of Ceramide III in propylene glycol by gavage at a dose of 5000 mg/kg bw and daily observed for 14 days. Body weight was determined at day 1 (pre-administration), 8 and 15.
Ceramide III was administered as 2 dosages of 2500 mg/kg bw within 24 hours. Multiple dosages given within 24 hours are regarded as a single dose.
No animal died. Apart from ataxia noted after each dosing, no other signs of ill health or behavioural changes were observed during the study period and no macroscopic toxicologically significant abnormalities were noted at necropsy at the end of the experimental period.
Oral LD50 (rat) > 5000 mg/kg bodyweight
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