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EC number: 225-806-1 | CAS number: 5089-72-5
- 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:
- weight of evidence
- Study period:
- 16.09.1991 to 19.10.1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 1992 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".
Test material
- Reference substance name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- EC Number:
- 217-164-6
- EC Name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- Cas Number:
- 1760-24-3
- Molecular formula:
- C8H22N2O3Si
- IUPAC Name:
- N-(2-Aminoethyl)-3-aminopropyltrimethoxysilane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: 300-500 g
- Housing: by sex and in groups of up to 5 or 6 (2 for the preliminary studies), in polystyrene cages with perforated flooring
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sterile Codex liquid paraffin
- Concentration / amount:
- Intradermal injections: 0.1%
Epicutaneous induction: 10%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sterile Codex liquid paraffin
- Concentration / amount:
- Topical challenge: 10%
- No. of animals per dose:
- Control: 20
Test: 20 - Details on study design:
- Induction
Treated group:
By intradermal route: 3 series of 2 x 0.1 ml injections.
1) FCA at 50% (v/v) in an isotonic injectable solution;
2) test substance in a 0.1% (v/v) solution in sterile Codex liquid paraffin;
3) mixture 50/50 (v/v): test substance in a 0.2% (v/v) in sterile Codex liquid paraffin + FCA at 50% (v/v) in an isotonic injectable solution, i.e. a final 0.1% concentration of the test substance.
By topical occlusive route for 48 hours: with 0.5 ml of the test substance in a 10% (v/v) solution in sterile Codex liquid paraffin. As this application only provoked a weak irritation during the preliminary study, a skin painting was performed on Day 8, with 0.5 ml of sodium lauryl sulfate at 10% (w/w) in Codex paraffin.
Control: The intradermal injections and the topical occlusive application for 48 hours were carried out under the same conditions as in the treated group, sterile Codex liquid paraffin replacing the test substance.
The rest period was 11 days without treatment.
Challenge
Topical occlusive application for 24 hours performed in the treated and control groups with the test substance in a 10% (v/v) solution in
sterile Codex liquid paraffin and at a rate of 0.5 ml. The vehicle was also applied during the challenge.
The cutaneous macroscopic examinations were performed according to Magnusson & Kligman scale and to the challenge application site, 24 and 48 hours after removal of the patches. Histopathological examinations of the skin were performed for nine animals of the treated group that showed doubtful macroscopic reactions at 24 hours and for one animal of the control group, which showed abnormal macroscopic reactions at 24 hours. - Challenge controls:
- The control group is actually a chellenge control.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction 0.1 % (v/v); challenge 10% (v/v)
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction 0%; challenge 10% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction 0.1 % (v/v); challenge 10% (v/v)
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction 0%; challenge 10% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Signs of irritation were noted during the induction.
The macroscopic and histopathological examinations revealed pathological lesions of delayed hypersensitivity in 6 out of the 20 treated animals. A weak irritation was noted in one animal of the control group. No other cutaneous abnormality was noted in the 19 other guinea pigs examined in the control group.
Overall, the test substance provoked a reaction of cutaneous sensitisation in 30% of the animals examined.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In a guinea pig maximisation study conducted to OECD 406 and to GLP the test material provoked a positive reaction in 30% of the test animals. Hence, this test substance is considered to be a skin sensitiser.
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