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EC number: 243-957-1 | CAS number: 20667-12-3
- 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
Endpoint summary
Administrative data
Description of key information
Reliable guideline conform in-vivo studies are available for skin and eye irritation of disilver oxide (OECD guidelines 404 and 405). Based on these studies, disilver oxide is not irritating to the skin but causes serious damage to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-02-21 to 1989-02-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study. At the time of the study conduct, GLP was not compulsory. However, the study was conducted in accordance with the principles of GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: white russian (albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Pharma AG, Bielefeld
- Age at study initiation: 9 months (males) and 11 months (females)
- Weight at study initiation: 2.6 kg (males); 2.7 and 3.2 kg (females)
- Housing: stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH), individually housing
- Diet: approx. 120 g/day x animal (Standard diet, ssniff K, "Special Diet for Rabbits" supplied by ssniff Spezialfutter GmbH, D-4770 Soest)
- Water: ad libitum
- Acclimation period: 1 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 45 - 60
- Photoperiod: 12 hours dark/light - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: The opposite area of the treated dorsal skin was used as control site (no test material application).
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance were moistened with demineralised water and placed on the shorn dorsal skin.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.35 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after removal of the patches
- Number of animals:
- 3 rabbits (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: The test material was placed on the shorn dorsal skin area between shoulder and sacrum.
- Type of wrap if used: The site of application was covered with a linen cloth (approx. 6.25 cm2) which adhered to a synthetic film glue. A bandage wrapped several times around the trunk (Acrylastic, No. 2408, width 8 cm; P. Beiersdorf and Co. AG, Hamburg) provided a complete occlusion.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the end of the exposition time remaining test material was gently washed off as far as possible.
SCORING SYSTEM: The treated skin area was qualitatively (erythema/ eschar resp. edema) and quantitatively (values 0-4) assessed using the DRAIZE method. In addition, attention was paid to the occurrence of further reactions on the skin (e.g. corrosive effect) and to clinical symptoms (systemic toxic effects).
EVALUATION: The evaluation of the cutaneous irritation effect at observation times 1, 24, 48 and 72 hours p. appl. was expressed by an irritation index. A corresponding gradation was allocated to this index by the following scheme in a modified method according to Gilman et al. (1983):
0 - 0.5 = non irritant
0.6 - 3.0 = slightly irritant
3.1 - 5.0 = moderately irritant
5.1 - 8.0 = severly irritant - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The single application of 0.5 gram silver(I)-oxide to the intact skins of 3 rabbits caused no changes. During the observation period neither erythema nor edema could be detected.
- Other effects:
- The treated skin area was yellow to brown discoloured 24 hours after removal of the patch until the end of the 14-day observation period.
Systemic-toxic effects did not occur after dermal application of the test substance. The general condition of the test animals was not affected. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Silver(I)-oxide is not irritant to the skin
- Conclusions:
- The irritation index is 0.0.
Silver(I)-oxide therefore is a non-irritant in this test system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-04-10 to 1989-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: white russian (albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ASTA Pharma AG, Bielefeld
- Age at study initiation: 10 months (males); 10 and 11 months (females)
- Weight at study initiation: 2.53 kg (males); 2.78 and 2.94 kg (females)
- Housing: stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH), individually housing
- Diet: approx. 120 g/day x animal (Standard Diet, ssniff K, "Special diet for rabbits" supplied by ssniff Spezialfutter GmbH, D-4770 Soest)
- Water: ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 25.0
- Humidity (%): 40 - 60
- Photoperiod: 12 hours dark/light cycle - Vehicle:
- not specified
- Controls:
- other: The right eye of each animal was not treated and was used as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.08 g (representing a volume of about 0.1 ml) of the test substance were applied into the conjunctival sac of the left eye. Then both lids were briefly closed by gentle finger pressure. - Duration of treatment / exposure:
- "lids were briefly closed"
- Observation period (in vivo):
- 1 hour post application
- Number of animals or in vitro replicates:
- 3 rabbits (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was not rinsed.
SCORING SYSTEM: Signs of irritation on the cornea, iris and conjunctiva were assessed quantitatively and qualitatively using the DRAIZE scale. In addition, attention was paid to the occurrence of further reactions on the eyes (e.g. corrosive effect) and to clinical symptoms (systemic toxic effects).
TOOL USED TO ASSESS SCORE: The treated eyes were examined using a Cliptrix pencil light (supplied by Varta, Hannover, No. 645).
EVALUATION: An irritation index was not determined because of the corrosive effects. - Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Time point:
- other: 1 hour after treatment
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: animals were sacrificed
- Irritation parameter:
- cornea opacity score
- Remarks:
- (area of cornea involved)
- Basis:
- mean
- Time point:
- other: 1 hour after treatment
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: animals were sacrificed
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour after treatment
- Reversibility:
- other: animals were sacrificed
- Remarks on result:
- other: evaluation not possible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 1 hour after treatment
- Reversibility:
- other: animals were sacrificed
- Remarks on result:
- other: evaluation not possible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- mean
- Time point:
- other: 1 hour after treatment
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: animals were sacrificed
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour after treatment
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- other: animals were sacrificed
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The application of 0.08 g silver(I)-oxide into one conjunctival sac each of three rabbits caused severe changes. Because of the physical properties of the test substance the dose had to be limited to the a.m. level.
The cornea of all animals showed opacity of the whole corneal area (grade 4). The upper corneal area was olive-green discoloured.
An evaluation of the iris was impossible.
The conjunctiva of all animals was olive-green discoloured and the nictitating membrane of one animal parchment-like thinned. In addition, slight or obvious swelling with partial eversion of lids (grades 1 or 2) was observed.
Discharge with moistening of considerable parts around the eye (grade 3) was detected in two animals. - Other effects:
- The animals were sacrificed painlessly for reasons of animal protection.
In general, identical histopathological findings were present in all three animals. Severe acute coagulation necrosis of the mucosa and submucosal tissue, incl. glandular tissue, with complete loss of the epithelium and moderate edema were observed in conjunctiva and nictitating membrane. In the cornea complete loss of the corneal epithelium and hyalinization of the superficial layers of the corneal stroma were found.
There were no systemic toxic effects after conjunctival application of the test substance. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Silver(I)-oxide is corrosive to the eye.
- Conclusions:
- Silver(I)-oxide is corrosive in this test system.
Reference
A full evaluation of iris anc conjunctivae score was not possible (due to the severity of the effects the animals had to be sacrificed before conclusion of the normal observation period).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Whereas classification for skin irritancy is not required, disilver oxide requires classification as "H318: Causes serious eye damage" (Category 1) in accordance with the criteria laid down in Regulation (EC) 1272/2008.
Justification for classification or non-classification
Reliable guideline conform in-vivo studies are available for skin and eye irritation of disilver oxide (OECD guidelines 404 and 405). Based on these studies, disilver oxide is not irritating to the skin but causes damage to the eyes. Whereas classification for skin irritancy is not required, disilver oxide requires classification as "H318: Causes serious eye damage" (Category 1) in accordance with the criteria laid down in Regulation (EC) 1272/2008. Regarding respiratory irritation, inhalation is not a relevant route of exposure for disilver oxide, based on particle properties (size, dustiness, density). Thus, no classification for respiratory irritation is required.
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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