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EC number: 219-145-8 | CAS number: 2372-82-9
- 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:
- From October 23,1995 to January 03, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler test was conducted before the requirement for LLNA testing came into force.
Test material
- Reference substance name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- EC Number:
- 219-145-8
- EC Name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- Cas Number:
- 2372-82-9
- Molecular formula:
- C18H41N3
- IUPAC Name:
- bis(3-aminopropyl)(dodecyl)amine
- Test material form:
- liquid
- Details on test material:
- - Lot/batch No.: PN93-12
- Expiration date of the lot/batch: 21 September 1997
- Storage condition of test material: Room temperature in the dark
- Purity: 30.2%
- Physical state: A clear colourless liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England.
- Age at study initiation: Approx. 6-7 weeks
- Weight at study initiation: 270 to 315 g
- Housing: In groups of five in suspended metal cages with wire mesh floors
- Diet: A vitamin C enriched guinea-pig diet FD2, ad libitum.
- Water (e.g. ad libitum): Hay was given weekly.
- Acclimation period: 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approx. 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- a) for induction: 1% v/v (0.33% test substance) in distilled water
b) for challenge: 0.5% v/v (0.15% test substance) in distilled water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- a) for induction: 1% v/v (0.33% test substance) in distilled water
b) for challenge: 0.5% v/v (0.15% test substance) in distilled water
- No. of animals per dose:
- 20 per group
- Details on study design:
- RANGE FINDING TESTS: The topical irritancy of a range of dilutions of the test substance was investigated. Based on the results of this study, 1% v/v concentration was chosen for induction and 0.5% v/v concentration was chosen for challenge. The former concentration was the concentration that produced some irritation but did not give rise to adverse effects, while the latter was the maximum concentration not giving rise to irritating effects.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 20 test animals
- Control group: 10 negative control animals
- Site: Left shoulder region, 20 x 20 mm
- Frequency of applications: Days 1, 8 and 15
- Duration: 2 weeks
- Concentrations: 1% v/v
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after final induction
- Exposure period: 6 h
- Test groups: 20 test animals
- Control group: 10 negative control animals
- Site: Right flank, 50 x 50 mm
- Concentrations: 0.5% v/v
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patches
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Erythema, edema and dryness and sloughing of the epidermis
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.15%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Erythema, edema and dryness and sloughing of the epidermis.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Erythema, edema and dryness and sloughing of the epidermis
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.15%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Erythema, edema and dryness and sloughing of the epidermis.
- Key result
- Reading:
- other: Both readings: 24 and 48 h
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Erythema, edema and dryness and sloughing of the epidermis
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Both readings: 24 and 48 h. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Erythema, edema and dryness and sloughing of the epidermis.
- Reading:
- other: Overall result
- Group:
- positive control
- Dose level:
- 25%
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not considered to be sensitising to the skin of guinea-pigs.
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