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EC number: 700-340-6 | CAS number: 76524-94-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Mainzer Straße 80, D65189 Wiesbaden
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-[3-(triethoxysilyl)propyl]formamide
- EC Number:
- 700-340-6
- Cas Number:
- 76524-94-2
- Molecular formula:
- C10H23NO4Si
- IUPAC Name:
- N-[3-(triethoxysilyl)propyl]formamide
- Details on test material:
- - Name of test material (as cited in study report): Y-15864
- Physical state: liquid
- Lot/batch No.: TER00010-68-31
- Expiration date of the lot/batch: September 12, 2012
- Stability under test conditions: Not indicated by the sponsor
- Internal Test Item Number: S 1279711
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaCrl (pre-test), CBA/CaOlaHsd (main experiment)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Pre-test: Charles River UK, Manston Road, Margate, Kent CT9 4LT, United Kingdom; Main experiment: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: Pre-test: 10 - 11 weeks (beginning of treatment); Main study: 9 – 10 weeks (beginning of treatment)
- Weight at study initiation: Mean: 21.8 ± 1.4; Range: 18.9 - 24.1
- Housing: group housing in Makrolon Type II / III cages with wire mesh top (EHRET GmbH, 79302 Emmendingen, Germany) and granulated soft wood bedding (Rettenmaier & Söhne GmbH + Co. KG, 73494 Rosenberg, Germany)
- Diet: pelleted standard diet, ad libitum (Harlan Laboratories B.V., 5960 AD Horst, Netherlands)
- Water: tap water, ad libitum (Gemeindewerke, 64380 Rossdorf, Germany)
- Acclimation period: At least 5 days prior to the start of dosing under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25%, 50% (w/v), and 100% (undiluted test item)
- No. of animals per dose:
- 4 females (nulliparous and non-pregnant)
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which can be technically used, was 100% of the undiluted test item.
- Irritation: Pre-test with two animals was performed, highest non-irritating dose was 100%
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymphnode Assay
- Criteria used to consider a positive response: Exposure to at least one concentration of the test item resulted in an incorporation of 3
HTdR at least 3-fold or greater than that recorded in control mice and a clear dose response.
TREATMENT PREPARATION AND ADMINISTRATION:
- The application volume, 25 µL/ear/day, was spread over the entire dorsal surface (8mm diameter) of each ear once daily for three consecutive days
- A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
- 3 H-methyl thymidine (3HTdR) was purchased from Hartmann Analytic, 38124 Braunschweig, Germany (specific activity, 2 Ci/mmol; concentration, 1 mCi/mL).
- Five days after the first topical application (day 6) 250 µL of phosphate-buffered saline (PBS) containing 20.4 VCi of 3 HTdR (equivalent to 3 HTdR 81.4 VCi/mL) were injected into each test and control mouse via the tail vein.
- Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Pentobarbital-Natrium (Release, WDT, 30827 Garbsen,Germany).
- 8 lymph nodes per group were pooled and level of 3HTdR incorporation was measured as the number of radioactive disintegrations per minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The EC3 value was calculated according to the equation
EC3=(a-c) [(3-d)/(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the coordinates of the two pair of data lying immediately above and below the S.I. value of 3 on the local lymph node assay dose response plot.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 25%: 1.24 50%: 4.68 100%: 14.81
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM/lymph node: 0 % (negative control): 140.3 25%: 173.3 50%: 656.4 100%: 2076.8
Any other information on results incl. tables
Calculation of EC3 (EC3 = Estimated concentration for a S.I. of 3) value:
EC3 = (a-c) [(3-d)/(b-d)] + c = 37.8% (w/v)
a,b,c,d = Co-ordinates of the two pairs of data lying immediately above and below the S.I. value of 3 on the LLNA dose response plot
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Skin sensitiser Cat. 1B, H317
DSD: Sensitising, R43 - Executive summary:
In a study according to OECD guideline 429 the test item Y-15864 was assessed for its possible skin sensitising potential by a local lymph node assay (LLNA). Concentrations of 25, 50% (w/v), and 100% (undiluted test item) were administered to 4 CBA mice per group. The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. Stimulation Indices (S.I.) of 1.24, 4.68, and 14.81 were determined with the test item at concentrations of 25%, 50% (w/v), and 100% (undiluted test item) in acetone:olive oil (4+1 v/v), respectively. A clear dose response was observed. The test item Y-15864 was found to be a skin sensitiser and an EC3 value of 37.8% (w/v) was derived.
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