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Diss Factsheets
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EC number: 939-039-1 | 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:
- 23 April 2013 --- 13 June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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 (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: 20231250
- Physical state: off-white solid
- Storage conditions: at room temperature, tightly closed in a dry and well-ventilated place
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: 204 g (range: 182 g to 222 g)
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed by three from the same group in polycarbonate cages with stainless steel lids
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: 14 May 2013 to 11 June 2013
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Batch N° MKBH4894V
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL
- Justification for choice of vehicle: as unsatisfactory solubility of the test item was obtained in drinking water treated by reverse osmosis, another vehicle was chosen from the following organic solvents (in order of preference): 0.5% methylcellulose aqueous solution and corn oil. A homogenous suspension was obtained in corn oil at the concentration of 200 mg/mL.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.
DOSAGE PREPARATION (if unusual): the test item was administered as a homogenous suspension in the vehicle. The test item was ground to a fine powder, using a mortar and pestle, and then mixed with the required quantity of vehicle.
Fresh dose formulations were prepared on the day of each administration and kept at room temperature prior to administration.
CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: since no relevant toxicity data were available for the estimation of a lethal dose-level, the starting dose level was 300 mg/kg bw. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per treatment step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment, then on day of treatment (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed in any animals.
- Gross pathology:
- There were no findings considered to be related to the test item administration.
Dilatation of the uterus with translucent content was seen in one female given the test item at 2000 mg/kg (group 2). This is a common background finding in females rats related to the estrous cycle.
A white mass was found in the mammary gland from one female given the test item at 300 mg/kg. Although this macroscopic finding is unusual at this age, it was considered to be incidental in view of its isolated occurrence and the short duration of the observation period.
Any other information on results incl. tables
Table 7.2.1/1: Mean body weight and body weight changes (g) in treated animals during the observation period compared to laboratory historical control data
Sex |
Female |
|||
Group |
Laboratory Historical control data |
1 |
2 |
3 |
Dose-level (mg/kg) |
0 |
300 |
2000 |
2000 |
Body Weight (g) ± SD |
||||
. Day 1 |
208 (± 11.7) |
216 (± 9.8) |
207 (± 8.2) |
188 (± 10.1) |
. Day 8 |
246 (± 12.7) |
251 (± 12.5) |
243 (± 16.3) |
224 (± 10.7) |
. Day 15 |
266 (± 14.0) |
272 (± 12.4) |
264 (± 9.6) |
245 (± 9.1) |
Body weight Change (g)± SD |
||||
. Days 1-8 |
+39 (± 5.1) |
+35 (± 3.1) |
+36 (± 10.0) |
+36 (± 1.2) |
. Days 8-15 |
+20 (± 6.3) |
+21 (± 1.0) |
+21 (± 6.9) |
+21 (± 2.6) |
. Days 1-15 |
+58 (± 5.8) |
+56 (± 2.3) |
+57 (± 3.5) |
+57 (± 2.1) |
SD: standard deviations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD0 of the test item was equal or higher than 2000 mg/kg bw in rats.
- Executive summary:
The substance was tested for acute oral toxicity according to OECD 423 guideline and in compliance with Good Laboratory Practices.
The test item was administered once by gavage to 3 groups of 3 fasted female rats under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil. Since no relevant toxicity data were available for the estimation of a lethal dose-level, the starting dose-level was 300 mg/kg bw for ethical reasons. After the first assay, the next higher dose-level of 2000 mg/kg bw was tested. Then, as no toxicity was observed at this higher dose-level, the results were confirmed in other 3 females at 2000 mg/kg bw.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded before treatment then on day 1, 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination.
No unscheduled deaths occurred during the study and no clinical signs were observed in any animals. Body weight gain was unaffected by the test item treatment, when compared to laboratory historical control data. The test item administration did not induce any macroscopic findings at necropsy.
The acute oral LD0 of the test item was equal or higher than 2000 mg/kg bw.
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.
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