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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Before application, animals no. 2 and 3 showed slight redness around the application site, but not at the site where patch was applied. The redness could be due to shaving. This deviation did not influence the quality or integrity of the present study, as
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld
- Age at study initiation: approximately 11 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: The untreated right side served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): Not stated. The test item was applied first to a gauze patch at a single dose. To ensure good skin contact, it was moistened with aqua ad injectionem. - Duration of treatment / exposure:
- 4 h
- Observation period:
- Animals no. 1, 2 and 3 were observed for 3, 9 and 6 days, respectively, after the patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm² on the left side of the dorsal area.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the residual test item was removed by using tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scores
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 1.34
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0.34
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema 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 showed irritant but reversible effects on the intact skin of 2 female rabbits (strain NZW) after a contact time of 4 hours (Tables 1 and 2).
Before application, animals no. 2 and 3 showed slight redness around the application site, but not at the site where patch was applied.
From days 2-8 in animal no. 2, and from days 3-5 in animal no. 3, both the test site as well as the control site showed redness, which was more in the beginning and thereafter reduced. - Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed.
Any other information on results incl. tables
Table 1. Dermal irritation evaluation.
|
Hours after patch removal |
||||||||
Animal number |
Application site |
1 h |
24 h |
48 h |
72 h |
||||
|
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
Test site control |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
2 |
Test site control |
0 0 |
0 0 |
0 0 |
0 0 |
2 2 |
1 1 |
4* 4* |
0 0 |
3 |
Test site control |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
4* 4* |
0 0 |
* Redness and eschar was seen also outside the application area, and on the control side also. It was considered a late reaction probably due to shaving.
|
Days after patch removal |
||||||||
Animal number |
Application site |
4 d |
5 d |
6 d |
7 d |
||||
|
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
Test site control |
- - |
- - |
- - |
- - |
- - |
- - |
- - |
- - |
2 |
Test site control |
4# 4# |
0 0 |
2# 2# |
0 0 |
1# 1# |
0 0 |
1# 1# |
0 0 |
3 |
Test site control |
4# 4# |
0 0 |
1# 1# |
0 0 |
0# 0# |
0 0 |
- - |
- - |
#slight scales present on both the treated and control site.
|
Days after patch removal |
||||
Animal number |
Application site |
8 d |
9 d |
||
|
Erythema |
Edema |
Erythema |
Edema |
|
1 |
Test site control |
- - |
- - |
- - |
- - |
2 |
Test site control |
1# 1# |
0 0 |
0 0 |
0 0 |
3 |
Test site control |
- - |
- - |
- - |
- - |
#slight scales present on both the treated and control site.
Table 2. Individual data
Individual systemic and local findings |
|||||||||
Time after patchremoval |
Animal number 1 |
Animal number 2 |
Animal number 3 |
||||||
systemicfindings |
specific |
comments |
systemicfindings |
spectfic local |
comments |
systemicfindings |
specific |
comments |
|
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 |
eschar |
- |
nsf |
eschar |
- |
4 days |
- |
- |
- |
nsf |
slight |
- |
nsf |
slight |
- |
5 days |
- |
- |
- |
nsf |
slight |
- |
nsf |
slight |
- |
6 days |
- |
- |
- |
nsf |
slight |
- |
nsf |
slight |
- |
7 days |
- |
- |
- |
nsf |
slight |
- |
- |
- |
- |
8 days |
- |
- |
- |
nsf |
slight |
- |
- |
- |
- |
9 days |
- |
- |
- |
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 dermal application of the test item Rice husk ash to rabbits at a dose of 0.5 g showed irritant effects in 2 out of 3 animals which were fully reversible within 9 days in animal no. 2 and within 6 days in animal no. 3.
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 skin 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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