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EC number: 221-336-6 | CAS number: 3069-29-2
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08/01/1988-12/02/1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA 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:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
- EC Number:
- 221-336-6
- EC Name:
- N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
- Cas Number:
- 3069-29-2
- Molecular formula:
- C8H22N2O2Si
- IUPAC Name:
- N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine
- Reference substance name:
- N-[3-(dimethomethoxymethylsilyl)propyl]ethylenediamine
- IUPAC Name:
- N-[3-(dimethomethoxymethylsilyl)propyl]ethylenediamine
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Interfauna (UK) Ltd., Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 315-395 g
- Housing:The animals were housed in groups of up to 4 in solid-floor polypropylene cages furnished with softwood shavings.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-23
- Humidity (%): 35-60
- Air changes (per hr): ca.15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- INDUCTION: First exposure: a row of three injections (0.1 ml each), Freunds Complete Adjuvant plus distilled water in the ratio of 1:1, 0.1% (w/v) dilution of test material in distilled water, 0.1% (w/v) dilution of test material in a 1:1 preparation of Freud's Complete Adjuvant plus distilled water. Second exposure: undiluted test material.
CHALLENGE: undiluted
Intradermal induction: 0.1% (w/v) in distilled water
Topical induction: undiluted as supplied
Topical challenge: undiluted as supplied
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- INDUCTION: First exposure: a row of three injections (0.1 ml each), Freunds Complete Adjuvant plus distilled water in the ratio of 1:1, 0.1% (w/v) dilution of test material in distilled water, 0.1% (w/v) dilution of test material in a 1:1 preparation of Freud's Complete Adjuvant plus distilled water. Second exposure: undiluted test material.
CHALLENGE: undiluted
Intradermal induction: 0.1% (w/v) in distilled water
Topical induction: undiluted as supplied
Topical challenge: undiluted as supplied
- No. of animals per dose:
- 20 (test), 10 (control) animals
- Details on study design:
- RANGE FINDING TESTS: The dose level for each of the three stages of the main study were determined using one or two guinea pigs and up to four dose levels tested on each animal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: First exposure: a row of three injections (0.1ml each), Freunds Complete Adjuvant plus distilled water in the ratio of 1:1, 0.1% (w/v) dilution of test material in distilled water, 0.1% (w/v) dilution of test material in a 1:1 preparation of Freud's Complete Adjuvant plus distilled water. Second exposure: undiluted test material.
- Control group: identical to test group but without test material
- Site: shoulder region of each animal
- Exposure period: one week, followed by a 48-hour occlusive exposure.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2
- Site: right flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde (40% aqueous solution)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- desquamation and thickening of skin
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- 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:
- undiluted
- 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:
- 20% v/v
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20% v/v
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The test material is reported to be an extreme sensitiser to guinea pig skin in a study conducted according to OECD Test Guideline 406 and in compliance with GLP.
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