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EC number: 439-510-7 | CAS number: 149048-48-6
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 June 2018 to 19 July 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because the test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- -
- EC Number:
- 439-510-7
- EC Name:
- -
- Cas Number:
- 149048-48-6
- Molecular formula:
- Constituent 1: C14H26N2O3Si Constituent 2: C13H22N2O2Si
- IUPAC Name:
- 1-(3-{13-[3-(aminomethyl)phenyl]-6,6,8,8-tetramethoxy-7-oxa-2,12-diaza-6,8-disilatridecan-1-yl}phenyl)methanamine; 1-[3-({[3-(trimethoxysilyl)propyl]amino}methyl)phenyl]methanamine
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl: HA - Guinea Pigs
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, German
- Females (if applicable) nulliparous and non-pregnant: n/a
- Microbiological status of animals, when known: The animals were derived from a controlled full-barrier maintained breeding system.
- Age at study initiation: approximately 5–6 weeks old
- Weight at study initiation: 328–383 g
- Housing: The animals were kept in groups in Terluran - cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs, rich in crude fibre, ad libitum.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 6 hours once a week for three weeks
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 0.006%
- Day(s)/duration:
- 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in the preliminary test: 12
Number of animals in the test group: 20
Number of animals in the negative-control group: 10 - Details on study design:
- RANGE FINDING TESTS: Before the initiation of the preliminary test, a solubility test was performed to define the maximum concentration which is technically applicable to the animals. Solubility was found for the vehicle dried cottonseed oil at a concentration of 95%. Adequate concentrations for the inductions and the challenge were determined by a preliminary test with different concentrations. Each concentration of the test item (emulsified with dried cottonseed oil) was applied topically to the flanks of the animals using occlusive dressings. The following concentrations were tested:
1 animal was treated topically with concentrations of 100% and 75% of the test item for 6 hours.
1 animal was treated topically with concentrations of 90% and 95% of the test item for 6 hours.
1 animal was treated topically with concentrations of 80% and 85% of the test item for 6 hours.
1 animal was treated topically with a concentration of 75% of the test item on both flanks for 6 hours.
1 animal was treated topically with concentrations of 50% and 60% of the test item for 6 hours.
1 animal was treated topically with concentrations of 30% and 40% of the test item for 6 hours.
1 animal was treated topically with concentrations of 20% and 10% of the test item for 6 hours.
1 animal was treated topically with concentrations of 2.5% and 1% of the test item for 6 hours.
1 animal was treated topically with concentrations of 0.5 and 0.25% of the test item on one flank and with concentrations of 0.1 and 0.05% of the test item on the other flank for 6 hours.
1 animal was treated topically with concentrations of 0.05% and 0.025% of the test item for 6 hours.
1 animal was treated topically with concentrations of 0.0125% and 0.006% of the test item for 6 hours.
1 animal was treated topically with a concentration of 0.006% of the test item on both flanks for 6 hours.
Based on the results of this preliminary test the following concentrations were chosen for the main test:
a concentration of 0.1% for the dermal inductions
a concentration of 0.006% for the challenge application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Exposure period: 6 hours once a week
- Test groups: test and negative control groups
- Control group: yes
- Site: left flank
- Frequency of applications: once a week for three consecutive weeks
- Duration: 6 hours
- Concentrations: 0.1% in cotton seed oil
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: one
- Exposure period: 14 days after the last induction
- Test groups: test and negative control groups
- Control group: yes
- Site: Both flanks
- Concentrations: 0.006% in cotton seed oil
- Evaluation (hr after challenge): at 24 and 48 hours - Challenge controls:
- A patch loaded with 0.5 mL of the vehicle was applied to an area of approximately 2.5 x 2.5 cm on the left flank at an untreated site (intraspecific control) and was held in contact with the help of an occlusive dressing for 6 hours.
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (25% in Vaseline) was 50%, confirming the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.006% in cotton seed oil
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Erythema grade 1
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.006% in cotton seed oil
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Erythema grade 1
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- cotton seed oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- cotton seed oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- mercaptobenzothiazole (25% in Vaseline)
- Remarks on result:
- other: The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (25% in Vaseline) was 50%, confirming the reliability of the test system.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the skin sensitisation study, conducted according to OECD TG 406 and in compliance with GLP, the test material caused positive reactions identified as sensitisation at the tested concentration in 10% of the test animals that were identified as sensitisation at the tested concentration. Therefore, the substance is not considered to be a sensitizer.
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