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EC number: 217-982-3 | CAS number: 2031-62-1
- 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
Skin Sensitization (OECD 406), guinea pig: not sensitizing (RA from CAS 2031-67-6)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema or edema in any animal. Mild desquamation at test substance site at 24 and 48 hour readings (observed in more males than females).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema or edema in any animal. Mild desquamation at test substance site at 24 and 48 hour readings (observed in more males than females).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 25%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema and edema in any animal. Desquamation in one animal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 25%; challenge: 10%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- No erythema/edema in males, Grade 1 erythema/edema in three females, where subsequent histopathology revealed no signs of cell mediated delayed hypersensitivity. 7/10 males and 4/10 females showed desquamation (including the three with erythema/edema).
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- but referred to regular positive testing in the laboratory
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In a guinea pig skin sensitisation study (guinea pig maximisation test) conducted to OECD 406 and to GLP the source substance triethoxy(methyl)silane did not induce any skin sensitization in any of the animals tested at any time point. There were no clinical signs of systemic toxicity. Thus, the source substance is considered to have no skin sensitising potential. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in skin sensitising potential.
Reference
Signs of irritation were noted during the induction. Although macroscopic examination showed grade 1 erythema/edema in 3 females 48 h after challenge subsequent histopathological examinations did not reveal any lesion of delayed hypersensitivity in the those animals. No noticeable cutaneous abnormality was noted in the 20 guinea pigs examined in the control group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data on the skin sensitisation of diethoxy(methyl)silane (CAS 2031-62-1) are available. Therefore, the risk assessment was performed based on the available data from the source substance triethoxy(methyl)silane (CAS 2031-67-6). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and in accordance with the Read across assessment framework (RAAF, ECHA 2017) read across from the analogue substance has been applied to support the human health hazard assessment of diethoxy(methyl)silane (CAS 2031-62-1). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
Studies were chosen as key when the available study was of relevance and of sufficient quality for classification and labelling and for risk assessment.
In a key guinea pig maximisation study conducted in compliance with GLP and according to OECD TG 406, triethoxy(methyl)silane was found to be a non-sensitiser. A group of ten male and ten female guinea pigs was dosed with multiple intradermal injections on day 0 following a topical application on day 7 in order to investigate sensitisation potential of triethoxy(methyl)silane. The topical induction consisted of a 48 hour occluded dermal exposure to 0.5 ml of the test substance in a 50% (v/v) solution in sterile codex liquid paraffin. Eleven days after topical induction, challenge dosing for detection of sensitisation was performed. For challenge dosing, an essentially non-irritating concentration (10% (v/v)) of the test material was applied under occlusion for 24 hours. Although macroscopic examination showed grade 1 erythema/oedema in 3 females 48 h after challenge subsequent histopathological examinations did not reveal any lesion of delayed hypersensitivity in those animals. Including these 3 females the sensitisation index was calculated to be 15% for the test group following rechallenge. Appropriate positive and negative controls gave expected results (Hazleton, 1992c).
In the absence of any chemical structural features indicative of sensitising potential for the submission substance and the number of negative results in tests with the other members of this group, it is concluded in a weight of evidence approach that substances of this group are not sensitising. Therefore the read-across to triethoxy(methyl)silane is appropriate.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of the structural analogue substance, triethoxy(methyl)silane (CAS 2031-67-6), do not meet the criteria for classification according to Regulation (EC) 1272/2008 or EU Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification of the registered substance.
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