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EC number: 255-615-9 | CAS number: 41999-70-6
- 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:
- weight of evidence
- Study period:
- 2006-08-02 to 2006-09-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- The study is performed before 2008, with report available in 2012.
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this reliable Buehler test was performed before entry into force of the REACH Regulation.
Test material
- Reference substance name:
- 2-[(3-aminopropyl)methylamino]ethanol
- EC Number:
- 255-615-9
- EC Name:
- 2-[(3-aminopropyl)methylamino]ethanol
- Cas Number:
- 41999-70-6
- Molecular formula:
- C6H16N2O
- IUPAC Name:
- 2-[(3-aminopropyl)(methyl)amino]ethan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E-015/2005-1
- Purity test date: 2005-10-24
- Purity: 99.01 wt% (GC)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: no data
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Hsd: POC DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan
- Age at study initiation: 4 weeks at start of dosing
- Weight at study initiation: 300-366 grams
- Housing: Animals were individually housed upon receipt and upon assignment to study in compliance with USDA Guidelines. Calvert is a USDA registered and fully AAALAC accredited facility. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
- Diet (e.g. ad libitum): All animals had access to Harlan Teklad Guinea Pig Diet (certified) ad libitum
- Water (e.g. ad libitum): Tap water was available ad /ibitum, to each animal via an automatic watering device
- Acclimation period: minimum of 7 days prior to dosing
- Indication of any skin lesions: not indicated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19° to 26°C
- Humidity (%): 45 to 80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- concentration:
100%
volume:
0.3 mL per site - Day(s)/duration:
- weeks 1 - 3: a total of three 6-hour exposures to the test item
- Adequacy of induction:
- other: concentration chosen for induction was generally one that produces mild irritation
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- concentration:
80%
volume: 0.3 mL per site - Day(s)/duration:
- weeks 1 - 3: a total of three 6-hour exposures to the test item
- Adequacy of induction:
- other: concentration chosen for induction was generally one that produces mild irritation
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- concentration:
70%
volume:
0.3 mL per site - Day(s)/duration:
- Fourteen days after the last induction
- Adequacy of challenge:
- other: highest concentration to be used was generally one in the vehicle used that induced no scores >= 1 and scores not exceeding two ± in the groupo of four animals
- No. of animals per dose:
- primary irritation test: 4; secondary screen: 4; test article: 20 (10m, 10f); positive control: 6 (3m, 3f); vehicle control: 10 (5m, 5f)
- Details on study design:
- RANGE FINDING TESTS:
Dose-Range-Finding Study
a) Primary Irritation Screens: Prior to initiation of the main study, the irritation potential was determined. Four naive animals were exposed to four different concentrations of the test material by the patching technique described in site preparation and treatment. The location of each of the four concentrations of test article differed in each of the four animals to compensate for any site-to-site variations. For grading of the response, the procedure described below for primary challenge was used, except that only 24-hour grades were obtained. The concentration chosen for induction was generally one that produces mild irritation. The highest concentration to be used for challenge was generally one in the vehicle used that induces no scores > = 1and scores not exceeding two ± in the group of four animals.
b) Secondary Irritation Screen: An additional irritation screen was performed using four additional animals. Doses of 60%, 70%, 80% and 90% were investigated to choose the second and third induction doses and the challenge dose.
The dose chosen for induction: 0.3 ml
The dose chosen for challenge: 0.3 ml
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Test groups: 80% and 100% of test material in physiological saline
- Control group: vehicle only
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 80% and 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hours
- Test groups: 70% of test material
- Control group: vehicle only
- Concentrations: 70%
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2, 4-dinitrobenzene (DNCB) (induction: 0.3% in 80% ethanol; challenge: 0.2% in acetone)
Results and discussion
- Positive control results:
- The positive control group, induced and challenged with DNCB, exhibited the anticipated positive responses at challenge, indicating that the methods employed in this study were valid.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 70%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- no signs of systemic toxicity and all animals gained weight during the study
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 70%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- no signs of systemic toxicity and all animals gained weight during the study
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- no signs of systemic toxicity and all animals gained weight during the study
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.2%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- no signs of systemic toxicity and all animals gained weight during the study
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of systemic toxicity and all animals gained weight during the study
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of systemic toxicity and all animals gained weight during the study
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 70% test item
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- no signs of systemic toxicity and all animals gained weight during the study
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 70% test item
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- no signs of systemic toxicity and all animals gained weight during the study
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the conditions of this study, induction with the test substance at 100 and 80% did elicit a delayed contact hypersensitivity response in guinea pigs when challenged with the test article at 70%.
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