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EC number: 243-606-2 | CAS number: 20217-01-0
- 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
one Guideline study on acute oral toxicity available.
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
- Study period:
- February - May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: CG272
- Expiration date of the lot/batch: 11. July 2018
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: assumed soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 13 weeks
- Weight at study initiation: 190 - 245 g
- Fasting period before study: no
- Housing: up to 3 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 ± 0.3°C
- Humidity (%): 53.6 ± 2.2 %
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 / 12
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: according to calculated dose
- Amount of vehicle (if gavage): not stated
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423
- Lot/batch no. (if required): L52897
- Purity: not stated
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose. - Doses:
- 300, 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: The animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no statistics applied during study
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 3/6 females survived the limit dose of 2000 mg/kg body weight and 6/6 females survived dose of 300 mg/kg.
1 animal of 3 died in the first step of 2000 mg/kg bw testing, 2 animals of 3 died in the second step of 2000 mg/kg bw. - Clinical signs:
- Test item-related mortality in females treated with the test item in dose of 2000 mg/kg body weight was observed within 24 hours in 2 females and one female on Day 5 post-treatment. Animal died presumably during the night hours, because cadaver was in a state of autolysis.
Lethargy was observed in one animal between 0.5 – 1 hour post-treatment. Other animals were lethargic from 2 hours to 5 days post-treatment.
No mortality was observed in females treated with the test item at dose of 300 mg/kg body weight Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered. - Body weight:
- The body weight of the surviving animals treated with the dose of 2000 mg/kg mildly increased in 2 animals and no change of body weight during the study was observed for one animal.
Stagnation of the body weight in animals (except one female) treated with the dose of 300 mg/kg was observed between first and second week after administration. - Gross pathology:
- All animals (except No 4; cadaver was autolysed) treated with the dose of 2000 mg/kg body weight were necropsied. During necropsy, no macroscopic findings were noticed.
All animals treated with dose of 300 mg/kg body weight were necropsied. During necropsy, no macroscopic findings were noticed. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test item DENACOL EX-147 is greater than 300 mg/kg body weight and lower than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item DENACOL EX-147 is classified in Category 4 with a LD50 cut off value 2000 mg/kg body weight, after single oral administration to Wistar rats. - Executive summary:
The test itemDENACOL EX-147 administeredto 6 females at limit dose of 2000 mg/kg body weight caused death of 3 females.Lethargy was observed within the observation period of 5 days post-treatment.Mild increase or stagnation of the body weight was observed.During necropsy, no macroscopic findings were observed.
The test itemDENACOL EX-147 administeredto 6 females at dose of 300 mg/kg body weight did not cause death. Nosigns of toxicity were observed in females during the first 4 hours or the 14-day observation period thereafter. Body weight stagnation in all animals (except one animal) was observed between week 1 and week 2.During necropsy, no macroscopic findings were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- one Guideline 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 classification or non-classification
For acute toxicity, oral route, the available information is conclusive and sufficient for classification as acute oral toxic, category 4.
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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