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Diss Factsheets
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EC number: 935-783-6 | 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
Acute Toxicity: oral
Administrative data
- 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: GLP compliant OECD 423 guideline study.
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)
- Version / remarks:
- (2001)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2009-02-09, North Rhine-westphalia
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Preventol KMX
- IUPAC Name:
- Preventol KMX
- Details on test material:
- - Name of test material (as cited in study report): Preventol KMX
- Physical state: colorless liquid
- Analytical purity: 100%
- Lot/batch No.: CHK 2109
- Expiration date of the lot/batch: 2011-09-21
- Stability under test conditions: Ensured by the sponsor
- Storage condition of test material: At room temperature due to product information by the sponsor
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar HsdCpb:Wu
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, 5960 AD Horts, Netherlands
- Age at study initiation: approx. 8 - 12 weeks (assumed by the body weight)
- Weight at study initiation: 156 g - 174 g
- Housing: grouped
- Diet: Provimi Kliba 3883 PM S15 Maus/Ratte Haltung, Kaiseraugust Switzerland; ad libitum, except for the day before administration of the test substance. Food was withheld from the animals for 16- 24 h before and 2-4 h after administration of the test substance.
- Water: tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 5%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG400
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females at 2000 mg/kg bw
2x3 females at 300 mg/kg bw - Control animals:
- no
- Details on study design:
- - Starting dose: 2000 mg/kg bw
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality were determined several times at the day of application (defined as day 1) and at least once daily thereafter. The weight gain was checked weekly.
Animals which died or were sacrificed in a moribund state were weighed and subjected to gross pathology
- Necropsy of survivors performed: yes - Statistics:
- A validated LAN-linked computer system was used for data collection, processing and evaluation.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2/3 animals of the high dose group died during the observation period.
No mortalities occured at 300 mg/kg bw. - Clinical signs:
- Clinical signs at 2000 mg/kg bw comprised of: decreased motility, lateral position, abdominal position, tremor, narrowed palpebral fissure, piloerection and labored breathing.
No clinical signs were observed in animals of the 300 mg/kg bw dose group. - Body weight:
- No significant effects on body weight or body weight gain were noted.
- Gross pathology:
- Gross pathology of the two animals which died during the observation period revealed dilated intestine/stomach (gas filled). The animal of the high dose group sacrificed at study termination showed a spotted lung.
No gross pathological changes were noticed in any animal treated with 300 mg/kg bw.
Any other information on results incl. tables
Table 1: Table for acute oral toxicity.
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Females |
||||
2000 |
2/3/3 |
10 min – 7 h |
3 h – 6 h |
67 |
300 (1st ) |
0/0/3 |
-- |
-- |
0 |
300 (2nd ) |
0/0/3 |
-- |
-- |
0 |
LD50 = >300 – 2000 mg/kg |
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Acute oral Cat 4, H302
DSD: Xn, R22
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