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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-3 (Subchronic Dermal Toxicity 90 Days)
- Deviations:
- yes
- Remarks:
- see, principles of method if other than guideline
- Principles of method if other than guideline:
- The high dose level was lowered because of the severe irritation (eschar formation) of the application skin site as it could potentially decrease dermal absorption of the test substance. This change was not considered to effect the integrity of the study.
- GLP compliance:
- yes
- Limit test:
- no
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 hours/day, 90 days
- Frequency of treatment:
- 5 days a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.25%, 0.5% and 1.0% a.i. (1.0% reduced to 0.75% after approximately one week of dosing), corresponding to 5, 10 and 20 (15) mg a.i./kg bw/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- Cohort I : 46 rats/sex,
5 dose groups of 8 rats/sex/group
Cohort II: 69 rats/sex
4 groups of 15 rats/sex/group - Control animals:
- yes
Results and discussion
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- (systemic effects)
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no effects at any tested dose
- Key result
- Dose descriptor:
- LOAEL
- Remarks:
- (local effects)
- Effect level:
- 5 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- dermal irritation
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
NOEL was established at 15 mg a.i./kg bw. No evidence of an immunotoxicity or systemic toxicity was seen following dermal application of the test substance at dose levels up to 15 mg/kg bw for 6-7 (immuntoxicity evaluation) or 13-14 (systemic toxicity) weeks. All effects seen in the study were attributed to local irritation caused by dermal application of the test substance. With respect to local skin effects, no NOAEL was established.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the 90 d NOEL of the test substance was established at 15 mg a.i./kg bw in rats.
- Executive summary:
A study was conducted to determine dermal repeated dose toxicity of the test substance to Sprague Dawley rats for a minimum of 90 d according to EPA OPP Guideline 82-3, in compliance with GLP. Animals were exposed to the test substance at concentrations of 5, 10 and 20 (15) mg a.i./kg bw/day for duration of 6 h/day. There were no evidence of immunotoxicity or systemic toxicity following dermal application of the test substance at dose levels up to 15 mg a.i./kg bw/day for 6-7 (immunotoxicity evaluation) or 13-14 (systemic toxicity) weeks. All effects seen in the study were attributed to local irritation. With respect to local skin effects, no NOAEL was established. Under the study conditions, the 90 d NOEL of the test substance was established at 15 mg a.i./kg bw in rats (Johnson, 2000).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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