Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-801-1 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April to June 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test performed according to OECD/EU testing guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Bottom product of propylene oxide and styrene production
- IUPAC Name:
- Bottom product of propylene oxide and styrene production
- Details on test material:
- - Name of test material (as cited in study report): KORE grade V
- Substance type: UVCB
- Physical state: Brown viscous liquid
- Stability under test conditions: months
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: from the copany Charles River Deutschland GmbH, D-97633, Sulzfeld
- Age at study initiation: data not available
- Weight at study initiation: between 153g and 163g
- Fasting period before study: yes
- Housing: the rats were kept in transparent macrolone cages (type 3-180, floor area 810 cm2) with 3 in each cage. the cages were cleaned and the bedding changed at least twice a week.
- Diet: free access to a pelleted diet "Altromin 1324"
- Water: free access to bottles of drink water of domestic quality, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: at least 30% and preferably not exceed 70%
- Air changes: 10 times/hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From 02-NOV-2009 to 24-NOV-2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: data not available
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: data not available - Doses:
- 300 mg/kg bw
2000 mg/kg bw - No. of animals per sex per dose:
- 4 x 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> each rat was observed 30 minutes, 2 hrs, 4hrs and 6hrs after the administration and therafter daily for a period of 14 consecutive days
> the body weight was determined on days 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed at this dose
- Mortality:
- All six animas survived the treatment with the test item.
- Clinical signs:
- In group 1, a hunched posture and piloerection were observed in animals No. 1, No. 2 and No. 3 on the day of application after 30 minutes. After 2hrs, 4hrs and 6hrs the three rats showed piloerection. Piloerection was also observed in animal No. 1 on day 1, whereas animals No. 2 and No. 3 showed normal behaviour. From day 2 to the end of the observation period, all three animals were free of any abnormalities.
In group 2, a hunched posture and piloerection were observed in animals No. 4, No. 5 and No. 6 on the day of application after 30 minutes and 2hrs. After 4hrs all three animals still showed piloerection as well as after 6hrs animals No. 4 and No. 6 only. Normal behaviour was observed in animal No. 5 after 6 hrs. From day 1 to the end of the observation period all three animals were free of any abnormalities. - Body weight:
- The body weight increased in each animal indicating a physiological development.
- Gross pathology:
- in the autopsy, no pathological sign was detected
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- oral LD50 (rat, females) > 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity study (OECD 423, GLP), groups of fasted, Wistar rats (4 x 3 females) were given a single oral dose of KORE GRADE V - Bottom product of propylene oxide and styrene production (Batch: 21/10/2010) in olive oil. Whereat two groups at the dose of 300 mg/kg bw and two other groups at 2000 mg/kg bw. All groups were observed for 14 days.
Oral LD50 (females) > 2000 mg/kg bw
No mortality and no effect on body weight were observed.
There were no pathological signs detected in the necropsy, with exception of animal No. 9. The spleen of this rat was slightly swollen.
Signs of toxicosis ranging between slight to severe were observed in the animals.
The study is considered as valid. According to this result, KORE GRADE V - Bottom product of propylene oxide and styrene production is not classified according to EU criteria (directive 67/548/EEC and CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.