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Diss Factsheets
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EC number: 942-166-5 | 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
one available in vivo acute oral toxicity study available. This study does not lead to a classification as acute toxic.
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:
- other: OECD Guidline Study performed under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: OrientBio Inc. 143-1 Sangdaewon-dong, Joongwon-gu, Seongnam-si, Gyonggi-do, Korea
- Age at study initiation: 8-9 week
- Weight at study initiation: 163.4 - 186.4 g
- Fasting period before study: 16 h
- Housing: individual
- Diet: standard ad libitum
- Water: filtered and sterilized drinking water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 23.1
- Humidity (%): 38.1 - 56.5
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 /12 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 60 g/l (300 mg/kg bw) or 400 g/l (2000 mg/kg bw)
- Amount of vehicle (if gavage): 5 ml/kg
- Justification for choice of vehicle: according to the sponsors information and preliminary test, olive oil was selected since the test substance was dissolved into olive oil.
- Lot/batch no. (if required): 115K6046
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:as no information was present, the starting dose was selected according to OECD Guideline 423. - Doses:
- 300 mg/kg bw, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs: once per day, body weight: before dosing, on day 3, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no statistics performed
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed, all animals survived to the scheduled termination
- Clinical signs:
- other: no abnormal clinical signs
- Gross pathology:
- no macroscopic findings
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 established in the present Study according to Guideline OECD 423 is
LD50 > 2000 mg/kg bw.
Therefore the substance has not to be treated as toxic after single dose via oral route and has not to be classified. - Executive summary:
This study was performed to evaluate the acute toxicity and LD50 for a single oral administartion of Nomcort SG in rats. In step 1 and 2 of 300 mg/kg and in step 3 and 4 of 2000 mg/kf of the test substance were administered orally into 3 female rats per each step. Clinical signs and body weight changes were observed for 14 days after the administration and gross findings at the necropsy were observed on day 14.
Throughout the treatment from step 1 to step 4, there were no tratment-related differences noted in the body weight data and mortality.
Throughout the treatment from step 1 to step 4, there were no abnormal clinical signs during the observation perios.
In the necropsy, there were no macroscopic abnormalities in all animals in step 1, 2, 3 and 4.
In conlusiont, the test substance Nomcort SG in relation to the acute oral administration was classified as unclassified. In addition, LD50 range was considered to be LD50 > 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:
- only one in vivo study available.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of acute toxicity – oral endpoint
only one in vivo study available. This study is reliable and
appropriate.
Justification for classification or non-classification
The presented information is conclusive but not sufficient for classification.
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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