Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-104-5 | CAS number: 762-72-1
- 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 sensitisation (OECD 429), LLNA: not sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 April - Jul 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 06 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc., Postbus 6174, 5960 AD Horst / The Netherlands
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 18.5 ± 1.6
- Housing: group housed in Makrolon Type II (pre-test) / III (main study), with wire mesh top
- Diet: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 45-65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): artificial light 6.00 a.m. - 6.00 p.m. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, and 100% in acetone/olive oil (4+1, v/v)
- No. of animals per dose:
- 4 females/group
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which could be technically used was 100% (undiluted test item).
- Irritation: Local irritation were documented and a score was used to grade a possible erythema of the ear skin.
- Systemic toxicity: Clinical signs were recorded at least once daily. The body weights were recorded on day 1 (prior to dosing) and prior to treatment with 3HTdR.
- Ear thickness measurements: In the pre-test, the ear thickness was determined prior to the first application of the test item (day 1), on day 3, and on day 6 prior to sacrifice using a micrometer.
- Erythema scores: Measured according to Draize.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the Stimulation Index. Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 25, 50, and 100% in acetone/olive oil (4+1, v/v). The test material was applied to each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals). Five days after the first topical application, phosphate-buffered saline containing 3H-methyl thymidine was injected into each test and control mouse via the tail vein. Approximately five hours after treatment with 3HTdR all mice were euthanized after harvesting of the lymph nodes, followed by cervical dislocation. Harvested lymph nodes were dailed and pooled for each experimental group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- None reported
- Positive control results:
- The positive control showed a positive response, with SI of 1.48, 2.26, and 8.10 for 5, 10, and 25% of alpha-hexylcinnamaldehyde in acetone:olive oil (4:1 v/v), respectively.
- Key result
- Parameter:
- SI
- Value:
- 1.16
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.04
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 1.21
- Test group / Remarks:
- 100%
- Key result
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Remarks:
- The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
: In this study Stimulation Indices (S.I.) of 1.36, 1.04, and 1.21 were determined with the test item at concentrations of 25 and 50% in acetone/olive oil (4+1, v/v), and 100% (undiluted test item), respectively.
EC3 CALCULATION : The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
CLINICAL OBSERVATIONS: All treated animals survived the scheduled study period and no signs of systemic toxicity were observed. On day 3, all animals treated with the test item showed a very slight erythema of the ear skin (Score 1). The animals treated with the undiluted test item continued to show an erythema of the ear skin on test days 4 and 5. Additionally, the animals treated with 100% test item showed scaly ears.
BODY WEIGHTS: The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age. - Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In an OECD and GLP compliant LLNA study, the test item allyltrimethylsilane was not a skin sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a local lymph node assay (OECD 429; Dony, 2019), allyltrimethylsilane formulated in acetone/olive oil (4+1, v/v) was assessed for its possible skin sensitising potential using test item concentrations of 25, 50, and 100%. Results indicated that exposed animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. On test day 3 all treated animals showed a very slight erythema of the ear skin (Score 1). The animals treated with the undiluted test item continued to show an erythema of the ear skin on days 4 and 5. Additionally, the animals treated with 100% test item showed scaly ears. In this study Stimulation Indices (S.I.) of 1.36, 1.04, and 1.21 were determined with the test item at concentrations of 25 and 50% in acetone/olive oil (4+1, v/v), and 100% (undiluted test item), respectively. Based on these results, allyltrimethylsilane was not a skin sensitiser under the test conditions of this study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation indicate that allyltrimethylsilane does not meet the criteria for classification according to Regulation (EC) No 1272/2008, and is therefore conclusive but not sufficient for classification.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.