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EC number: 219-786-3 | CAS number: 2530-86-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N,N-dimethyl-3-(trimethoxysilyl)propylamine
- EC Number:
- 219-786-3
- EC Name:
- N,N-dimethyl-3-(trimethoxysilyl)propylamine
- Cas Number:
- 2530-86-1
- Molecular formula:
- C8H21NO3Si
- IUPAC Name:
- dimethyl[3-(trimethoxysilyl)propyl]amine
- Test material form:
- liquid
- Details on test material:
- EC No.: 219-786-3
- CAS No.: 2530-86-1
- Chemical Name: N,N-Dimethyl(aminopropyl)trimethoxysilane
- Batch No.: 1000095747
- Purity: 98.7%
- Physical State at Room Temperature: liquid
- Colour: colourless to yellowish
- Molecular Weight: 207.35 g/mol
- Storage Conditions: room temperature
- Stability in Container after Opening at Room Temperature: instable after repeated contact to air
- Stability in Water at Room Temperature: undergoes hydrolysis
- Expiry Date: 26 March 2017
- Safety Precautions: causes severe skin burns and eye damage
- Other Specification: in order to avoid degradation the test item vials will be flooded for storage with nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species/strain: healthy CBA/CaOlaHsD mice
- Source: Harlan Laboratories GmbH, 5800 AN Venray, The Netherlands
- Sex: female (nulliparous and non-pregnant)
- Age at the beginning of the study: 8-9 weeks
- Number of animals: 5 mice / group, 5 mice / prescreen test
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals are bred for experimental purposes.
The animals were randomly selected. Identification was ensured by cage number and individual marking (tail).
HOUSING AND FEEDING CONDITIONS
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- 5
- Details on study design:
- The LLNA has been developed as an alternative method for the identification of skin sensitising test items and measures the proliferation of lymphocytes isolated from lymph nodes (auricular lymph nodes) draining the site of exposure (dorsal aspect of the ears) in mice.
Lymphocyte proliferation is measured by determining the incorporation of 3H-methyl thymidine (TRK 300, 20 Ci/mmol, Lot 201310E, diluted to a working concentration of 80 µCi/mL). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The stimulation index of the positive control (25% α-Hexylcinnamaldehyde in AOO) was 5.7 and therefore the test is considered to be valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Remarks:
- (estimated by log linear interpolation)
- Value:
- 11.32
- Key result
- Parameter:
- SI
- Value:
- 4.6
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 6
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 6.8
- Test group / Remarks:
- 100%
Any other information on results incl. tables
PRESCREEN TEST
Neither signs of systemic toxicity nor signs of excessive irritation at any application site could be detected in any animal.
All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the duration of the prescreen test.
MAIN STUDY
Each of the three tested concentrations exceeded the stimulation index of 3.
The stimulation index at a concentration of 25% was 4.6
The stimulation index at a concentration of 50% was 6.0
The stimulation index at a concentration of 100% was 6.8
All animals survived throughout the test period without showing any clinical signs except for alopecia from day 2 to day 6 in animals treated with the undiluted test item.
All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- According to Commission Regulation (EU) No 286/2011 as well as GHS (Globally Harmonized Classification System) the test item has obligatory labelling requirement for skin sensitisation and is classified into Category 1B.
- Executive summary:
On the basis of the test results given below and in conformity with the criteria given in Commission Regulation (EU) No 286/2011 the substance should be:
classified into sub-category 1B
On the basis of the test results given below and in conformity with the criteria given in GHS (Globally Harmonized Classification System) the substance should be:
classified into sub-category 1B
Based on the results of the prescreen test the test item was assessed for sensitising properties at concentrations of 25% (v/v), 50% (v/v) , each diluted with AOO 4:1, (v/v)
and 100% (undiluted test item).
At the daily clinical observation no visible clinical symptoms were observed in any animal, except for alopecia at the application sites from day 2 to day 6 in the animals
treated with the undiluted test item. No case of mortality was observed.
Species/strain: Mice, CBA/CaOlaHsd
Number of animals: 25/main test
Vehicle: AOO (4:1 (v/v) acetone/olive oil)
Each of the three tested concentrations exceeded the stimulation index of 3.
The stimulation index at a concentration of 25% was 4.6
The stimulation index at a concentration of 50% was 6.0
The stimulation index at a concentration of 100% was 6.8
The stimulation index of the positive control (25% α-Hexylcinnamaldehyde in AOO) was 5.7 and therefore the test is considered to be valid.
The EC3 value (estimated by log linear interpolation) was calculated to be at a test item concentration of 11.32%.
Consequently, according to OECD 429 solutions or preparations containing more than 11.32% HV 720 are expected to have a stimulation index of >3 and are therefore
considered to be dermal sensitisers.
According to Commission Regulation (EU) No 286/2011 as well as GHS (Globally Harmonized Classification System) the test item HV 720 has obligatory labelling
requirement for skin sensitisation and is classified into Category 1B.
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