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EC number: 231-545-4 | CAS number: 7631-86-9
- 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
For the assessment of skin sensitisation of untreated SAS, a weight of evidence approach was used compiling data from repeated dose toxicity via the dermal route, absence of reported skin sensitization case during the past 20 years associated to monitoring of workers health and the use of this form of the substance in cosmetics products as reviewed by the Cosmetics Ingredients Review. Based on the long history of use and the absence of reported cases in humans and some studies, the generation of new data appears not required and no classification is warranted.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- In accordance with section 1.2 of REACH Annex XI, the available information for skin sensitization toxicity of unsurfaced treated synthetic amorphous silica was assessed in a “Weigh-of-Evidence” approach to identify potential concerns. In the case of untreated SAS adequate information is available in more than one study and therefore we applied a WoE based on the following data:
- Repeated dose toxicity : dermal exposure in vivo study
- Monitoring of workers in Germany exposed to SAS and the absence of reported case of skin sensitization.
- Long track record of use of untreated SAS in cosmetics products, including creams without reported case of sensitization.
- Several published studies were summarized in the last submission to the Cosmetics Ingredient Review Expert Panel Members, all the available sources showed no skin sensitization potential with studies on non-surface treated SAS at concentration ranging from 21 up to 45%
In a limited 3-week study from 1958, no systemic toxicity and no gross pathological or microscopic change was reported. No sign of sensitization was described in this study.
Additionally a study performed by Du Pont de Nemours from 1970 using patches has also been reviewed by the panel with the following summary reported:
Patches were applied for six days to the arms of 10 men and the arms or legs of 10 women. After a two-week interval, new patches were applied for 48 hours as a challenge test. Skin under the patches was examined at one, two, three and six days after the first application and on removal of the challenge patch. No skin reactions were seen at any examination on any subject.
Altogether, none of these studies showed any potential for skin sensitization of non-surface treated Silica. Additionally, and an additional source of information the Informationsverbund Dermatologischer Kliniken (Information Network of Departments of Dermatology) which is a network funded in 1988 of currently 58 dermatological departments in Germany, Switzerland and Austria prepared and extensive literature search on their internal database which is composed of datasets of about 285 000 patients. This research only highlighted two “potential” cases which could not be directly convincingly linked to untreated Synthetic Amorphous Silica as reported in the statement attached to this entry. This is also consistent with the long history of use of untreated SAS in cosmetics products like creams without reported case of sensitization to the substance which was also confirmed by reports published in the Cosmetics Ingredient review report where Hydrated Silica (up to 45%) and in formulation at 21.74% were not sensitizing in human repeat insult patch tests (HRIPT) or in guinea pig sensitization tests.
As an additional source of information, this conclusion is also supported by the absence of positive skin sensitization in the 7 studies performed on silanized SAS test materials.
Reference 1:
W.R. Grace & Co. 1981. Supplement to GRAS affirmation petition No. 1G0270: Silica gel for use as a carrier for flavors.
Reference 2:
1984. Safety data of hydrated silica - contact allergenicity (Translated into English in 2009). 5 pages
Reference 3:
KGL, Inc. 2003. An evaluation of the contact-sensitization potential of a topical coded product (facial mask containing 17% Hydrated Silica) in human skin by means of the maximization assay. KGL Protocol #5384. Unpublished data submitted by the Council June 3, 2009. 12 pages.
Reference 4:
KGL, Inc. 2004. An evaluation of the contact-sensitization potential of a topical coded product (face powder containing 21.7436% Silica) in human skin by means of the maximization assay. KGL Protocol #5632. Unpublished data submitted by the Council June 3, 2009. 12 pages.
Reference 5:
E. I. du Pont de Nemours and Company, Inc., unpublished, Report No.: 484-70 (1970) - Reason / purpose for cross-reference:
- data waiving: supporting information
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
No skin sensitization potential was identified for the different forms of the test material in the studies that are published and case have been reported during the long track record of workers or consumers exposed to untreated synthetic amorphous silica. According to Annex I of the Regulation (EC) 1272/2008 and GHS (Globally Harmonized Classification System), the test substance therefore requires no classification and has no mandatory label requirement
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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