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EC number: 266-587-2 | CAS number: 67151-63-7
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-07-14 to 1992-08-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed, before the LLNA was consdiered the default testing method for skin sensitisation potential.
Test material
- Reference substance name:
- 1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol
- EC Number:
- 266-587-2
- EC Name:
- 1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol
- Cas Number:
- 67151-63-7
- Molecular formula:
- C13H31N3O
- IUPAC Name:
- 1-Bis(3-(dimethylamino)propylamino)-2-propanol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Bis-(-3-dimethylaminopropyl)-amin
- Substance type: liquid, slight yellowish
- Physical state: liquid
- Analytical purity: 99%
- Lot/batch No.: 19b/KW 23857369582-8
- Stability under test conditions: The stability of the test sustance in aqua bidest. has not been determined analytically. The homogeneity of the test substance preparation was provided by stirring (only mixture with Freund's adjuvant).
- Storage condition of test material: Room temperature
- Other: The storage stability of the test substance over the study period was guaranteed by reanalysis. The sample appeared to be homogeneous
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, D-W4323 Exertal 1, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 292 - 341 g
- Housing: Makrolon, type IV cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days before the beginning of the study in the laboratory for dermal toxicity
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light ( 6.00 - 18.00 hours) 12 hours darkness (18.00 - 6.00 hours)
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.1% test substance in 0.9% aqueous NaCl solution or in Freund's adjuvant/0.9% aqueous NaCl solution (1:1) or 0.9% aqueous NaCl solution
Percutaneous induction: test substance 1% in aqua bidestilled
Challenge: test sbustance 0.5% in aqua bidest.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.1% test substance in 0.9% aqueous NaCl solution or in Freund's adjuvant/0.9% aqueous NaCl solution (1:1) or 0.9% aqueous NaCl solution
Percutaneous induction: test substance 1% in aqua bidestilled
Challenge: test sbustance 0.5% in aqua bidest.
- No. of animals per dose:
- Number of animals per control group: 5
Number of animals of the test group: 10 - Details on study design:
- RANGE FINDING TESTS:
Amount applied:
2x2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing (the bandage consists of rubberized linenpatches 4x4 cm (adhesive fleece)). The test filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.15 g of the test substance formulation.
Exposure period:
The test substance was applied 2 times for 24 hours with - in a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold.
Site of application: flank, respective on the same area
Number of test animals: 4 per test concentration
Readings: about 24 and 48 hours after the beginning of application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal induction: 6 intradermal injections in groups of two per animal
Injections for the test groups:
A) front row: 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1:1
B) middle row: 2 injections each of 0.1 mL of the test substance formulation
C back row: 2 injections each of 0.1 mL Freund's adjuvant/0.9% aqueous NaCl solution (1:1) with test substance
Injections for control groups 1 and 2:
The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent
Site of application: shoulder
Readings: 24h after the beginning of application
Percutaneous induction:
Percutaneous induction was carried out one week after intradermal induction.
Amount applied:
2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing (the bandage consists of rubberized linenpatches 4x6 cm (adhesive fleece)). The filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance formulation.
The control animals were not treated since the distilled water used as formulating agent was not expected to influence the result of the study.
Duration of exposure: 48 hours
Site of application: shoulder, same area as in the case of the previous intradermal application
Readings: 48 hours after the beginning of application
Assessment of skin findings: analogous to the pretest
B. CHALLENGE EXPOSURE
Test concentration: non-irritant concentration
Challenge 21 days after intradermal induction
Amount applied:
2x2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing (the bandage consists of rubberized linenpatches 4x4 cm (adhesive fleece)). The test filter paper strip was soaked in the test substance formulation: thus the animals were exposed to about 0.15 g of the test substance formulation.
- treatment of the test group with the test substance formulation
Duration of exposure: 24 hours
Site of application: intact flank
Readings: 24 and 48 hours after the removal of the patch
Assessment of skin findings: analogous to the pretest - Challenge controls:
- Treatment of control group 1 with the test substance formulation; control group 2 remained untreated
- Positive control substance(s):
- yes
- Remarks:
- 1-chlor-2,4-dinitro-benzol
Results and discussion
- Positive control results:
- The positive control with 1-chlor-2,4-dinitro-benzol showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5% in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5% in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5% in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reactions
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5% in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reactions
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- positive control substance in 1% ethanol
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- moderate to severe erythema and very slight edema in 2 out of 20 test group animals; 14 out of 20 animals of the test group showed well-defined erythema, 11 of them additionally exhibited very slight edema; very slight erythema in 4/20 test group animals
Any other information on results incl. tables
After the intradermal induction well-defined erythema and slight edema were observed at the injection sites of the control group animals and test group animals at which only Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) was applied. Injection of the test substance in 0.9% aqueous NaCl-solution caused well-defined erythema and very slight edema in the animals of the test group. After application of the test substance preparation in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) well-defined erythema and slight edema could be observed in the test group animals.
The control group animals which were treated with 0.9% aqueous NaCl-solution did not show any skin reactions.
The percutaneous induction was only carried out in the test group because with aqua bidest. a vehicle was used, that was not expected to influence the result of the study.
Incrustation, partially open (caused by the intradermal induction) in addition to well-defined erythema and slight edema could be observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study under the test conditions chosen and taking the above cited evaluation criteria into account , the test substance does not have a sensitising effect on the skin of the guinea pig in the maximization test. The substance is not to be classified according to CLP Regulation.
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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