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EC number: 297-049-5 | CAS number: 93333-79-0 The residuum from the burning of a combination of plants.
- 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:
- 15.2.2010-2.3.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was carried out in accordance with internationally valid GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Ashes (residues), plant
- EC Number:
- 297-049-5
- EC Name:
- Ashes (residues), plant
- Cas Number:
- 93333-79-0
- Molecular formula:
- Not applicable (UVCB Substance)
- IUPAC Name:
- Ashes (residues), plant
- Details on test material:
- - Name of test material: Ashes (residues) – Biomass Combustion
- Physical state: solid
- Substance type: technical product
- Appearance: black powder
- Composition of test material, percentage of components:
SiO2 37.81 % (w/w), K2O 17.01 % (w/w), CaO (total) 11.92 % (w/w), P2O5 6.15 % (w/w), Al2O3 4.05 % (w/w), SO3 (sulphate) 3.47 % (w/w), MgO 2.25 % (w/w), Fe2O3 1.81 % (w/w), CaO (free) 1.40 % (w/w), CO2 1.29 % (w/w), Na2O 0.60 % (w/w), TiO2 0.34 % (w/w).
- Impurities (identity and concentrations):
Metals: As, Be, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Tl, V, Zn sum <
0.1%
- Lot/batch No.: BMA/F/2009
- Expiration date of the lot/batch: 15 years / 12/2024
- Storage condition of test material: PE container, temperature bellow 40°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeding farm VELAZ, s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Age at study initiation: 8-10 weeks
- Weight at study initiation: see Table 1
- Fasting period before study: cca 20 h
- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage Velaz T4
- Diet (e.g. ad libitum): ST 1 BERGMAN – standard pelleted diet ad libitum, (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy)
- Water (e.g. ad libitum): drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C (permanently monitored)
- Humidity (%): 30-70 % (permanently monitored)
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Olive oil; Lot/batch no.: 4683401
- Expiration.: 04/2011
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION:
Immediately before application the test substance was weighed, mixed in vehicle (olive oil) and resulting suspension was administered to the stomach by tube. The single volume of administered suspension was 1ml/100 g of animal body weight.
CLASS METHOD:
- Rationale for the selection of the starting dose: according to methodology
Testing schedule (according to EU Method B.1 tris Annex 1D)
START: 2000 mg/kg – 3 females (Step No.1): no deaths ► 2000 mg/kg – 3 females (Step No. 2): no deaths ► END of study - Doses:
- 2000 mg/kg (bw)
- No. of animals per sex per dose:
- 3 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality: daily
- Frequency of observations: daily, after aplication the animals were observed individually
the first day: twice (30 minutes and 3 hours after application)
the second day: twice (in the morning and in the afternoon), daily thereafter for 14 days
Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
- Frequency of weighing:
before application, the 8th day and before euthanasia of animals (see Table 1)
- Necropsy of survivors performed: yes
All test animals survived to the end of study were sacrificed on the 15th day by injection of veterinary preparation T61 (1 ml iv.) and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no death animals
- Clinical signs:
- other: no clinical signs of intoxication
- Gross pathology:
- without pathologic changes
Any other information on results incl. tables
Table 1: Test results
Dose (mg/kg) (Step No.) |
Animal No. |
Body weight (g) |
Body weight gain (g) |
|||
Before |
8 days |
15 days |
0-8 days |
8-15 days |
||
2000 (1) |
1 |
158.30 |
187.40 |
202.62 |
29.10 |
15.22 |
2 |
144.68 |
179.79 |
194.94 |
35.11 |
15.15 |
|
3 |
159.02 |
191.22 |
205.17 |
32.20 |
13.95 |
|
mean |
154.00 |
186.14 |
200.91 |
32.14 |
14.77 |
|
SD |
8.08 |
5.82 |
5.33 |
3.01 |
0.71 |
|
2000 (2) |
4 |
163.75 |
199.26 |
218.03 |
35.51 |
18.77 |
5 |
153.00 |
177.99 |
190.60 |
24.99 |
12.61 |
|
6 |
155.68 |
191.12 |
205.87 |
35.44 |
14.75 |
|
mean |
157.48 |
189.46 |
204.83 |
31.98 |
15.38 |
|
SD |
5.60 |
10.73 |
13.74 |
6.05 |
3.12 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study. The test substance administered at the dose of 2000 mg/kg caused no death of animals.
No clinical signs of intoxication were observed during study in all six animals.
No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50 of the test substance, Ashes (residues) – Biomass Combustion, (in female rats) is higher than 2000 mg/kg of body weight. - Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance,Ashes (residues) – Biomass Combustion,after a single oral administration to Wistar rats.
The testing was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
Test substance wasadministered in a single dose as a solution in olive oil (vehicle), given orally via gavage to two groups of three female Wistar rats.
The dosing was performed sequentially in two groups of three females: group No. 1 - first step using the starting dose of 2000 mg/kg of body weight and group No.2 - second step using the same dose.
The test substance administered at the dose of 2000 mg/kg caused no death of animals.
No clinical signs of intoxication were observed during study in all six animals.
No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50of the test substance for female rats is higher than 2000 mg/kg of body weight.
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