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EC number: 275-735-5 | CAS number: 71630-92-7 Substance obtained by burning the husk removed from the rice paddy. Contains silica as well as the elements aluminum, calcium, carbon, chromium, copper, indium, iron, lead, magnesium, manganese, molybdenum, phosphorus, silver, sodium, tin, and zinc.
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Apr 2010 - 23 Apr 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
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:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, Munich, Germany
Test material
- Reference substance name:
- Ashes (residues), rice husk
- EC Number:
- 275-735-5
- EC Name:
- Ashes (residues), rice husk
- Cas Number:
- 71630-92-7
- Molecular formula:
- SiO2
- IUPAC Name:
- silanedione
- Details on test material:
- - Name of test material (as cited in study report): Rice husk ashes
- Physical state: crystalline black powder
- Analytical purity: >80%
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld
- Age at study initiation: approximately 28 weeks
- Weight at study initiation: > 2 kg
- Housing: ABS - plastic rabbit cages, floor 4200 cm2
- Diet (e.g. ad libitum): autoclaved hay and Altromin 2123 maintenance diet for rabbits (lot no. 0748), rich in erude fibre; ad libitum
- Water (e.g. ad libitum): tap water (drinking water, municipal residue control, microbiol. controlled periodically); ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated contralateral eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was rinsed with physiological sahne 0.9% NaCl .
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scores
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test item produced slight irritant but reversible effects after instillation into the eyes of 3 female rabbits (strain NZW) (Tables 1 to 3).
Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
Conjunctival discharge was observed 1 hour post-instillation in all test animals, which was reversible within 24 hours.
Conjunctival redness and chemosis were also observed in all test animals, and are described individually in Tables no. 1, 2 and 3. - Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed (Table 4).
Any other information on results incl. tables
Table 1: Eye Irritation Scores — Animal No. 1
Animal No. 1 |
|
Individual Data |
Average Score |
|||
|
Time Post Application |
|
||||
|
1 h |
24 h |
48 h |
72 h |
|
|
|
T/C |
T/C |
T/C |
T/C |
|
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
ConjunctivalRedness |
1/0 |
1/0 |
1/0 |
0/0 |
0.67 |
|
ConjunctivalChemosis |
2/0 |
1/0 |
0/0 |
0/0 |
0.33 |
T =test item, C = control
Table 2: Eye Irritation Scores — Animal No, 2
Animal No. 2 |
|
Individual Data |
Average Score |
|||
|
Time Post Application |
|
||||
|
1 h |
24 h |
48 h |
72 h |
|
|
|
T/C |
T/C |
T/C |
T/C |
|
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
ConjunctivalRedness |
1/0 |
1/0 |
0/0 |
0/0 |
0.33 |
|
ConjunctivalChemosis |
1/0 |
0/0 |
0/0 |
0/0 |
0 |
T = test item, C = control
Table 3: Eye Irritation Scores — Animal No. 3
Aninial No. 3 |
|
Individual Data |
Average Score |
|||
|
Time Post Application |
|
||||
|
1 h |
24 h |
48 h |
72 h |
|
|
|
T/C |
T/C |
T/C |
T/C |
|
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
ConjunctivalRedness |
1/0 |
1/0 |
1/0 |
0/0 |
0.67 |
|
ConjunctivalChemosis |
1/0 |
0/0 |
0/0 |
0/0 |
0 |
T = test item, C = control
Table 4: Individual Data
Individual.Systemic and Local Findings |
|||||||||
Time after |
Animal Number 1 |
Animal,Number 2 |
Animal Number 3 |
||||||
systemic |
Specific LocalFindings |
Com-ments |
Systemic |
Specific LocalFindings |
Com-ments |
Systemic |
Specific LocalFindings |
Com-ments |
|
1 h |
nsf |
nsf |
- |
nsf |
nsf |
- |
nsf |
nsf |
- |
24 h |
nsf |
nsf |
- |
nsf |
nsf |
- |
nsf |
nsf |
- |
48 h |
nsf |
nsf |
- |
nsf |
nsf |
- |
nsf |
nsf |
- |
72 h |
nsf |
nsf |
- |
nsf |
nsf |
- |
nsf |
nsf |
- |
nsf = no specific findings |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, single ocular instillation of the test item Rice husk ash to rabbits at a dose of 0.1 g produced slight irritant effects, which were fully reversible within 72 hours. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item Rice husk ash does not have to be classified and has no obligatory labelling requirement for eye irritation.
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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