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Diss Factsheets
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EC number: 913-660-8 | CAS number: -
- 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:
- 2004-03-01 to 2001-04-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- no positive control
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The tesing is finished before the REACH regulation came into force.
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]docosanamide
- EC Number:
- 262-134-8
- EC Name:
- N-[3-(dimethylamino)propyl]docosanamide
- Cas Number:
- 60270-33-9
- Molecular formula:
- C27H56N2O
- IUPAC Name:
- N-[3-(dimethylamino)propyl]docosanamide
- Test material form:
- solid
- Details on test material:
- - Name of test material: DIMAPDO lactate
- Molecular weight: 514.83 g/mol
- Analytical purity: 99.2 %
- Physical state: solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 weeks
- Weight at study initiation: 336 g (mean at induction)
- Housing: in groups of 5 animals in aluminum cages (W350 x D400 x H230: Natsume Seisakusho Co., Ltd.)
- Diet (e.g. ad libitum): solid food (RC4: Oriental Yeast Co., Ltd.), ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C
- Humidity (%): 50 ± 10%
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: for intradermal induction: physiological saline; for epicutaneous induction and challenge 50% ethanol in water
- Concentration / amount:
- intradermal induction: 0.01%
epicutaneous induction: 30%
challenge: 0.5%, 1%, 3%, 5%, 10%, 30%
Concentration selection based on a preliminary dose range finding study.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: for intradermal induction: physiological saline; for epicutaneous induction and challenge 50% ethanol in water
- Concentration / amount:
- intradermal induction: 0.01%
epicutaneous induction: 30%
challenge: 0.5%, 1%, 3%, 5%, 10%, 30%
Concentration selection based on a preliminary dose range finding study.
- No. of animals per dose:
- 8 (preliminary study); 10 (test group); 5 (control group)
- Details on study design:
- RANGE FINDING TESTS:
pilot experiment with 8 animals to determine which concentration of the test substance
- led to slight irritation after intradermal application (determination of the maximum compatible dose); concentrations tested: 0.01%, 0.03%, 0.05%, 0.1%, 0.5%, 1% and 5% (w/w)
- led to slight irritation after dermal application; concentrations tested: 0.3%, 0.5%, 1%, 3%, 5% and 10% (w/w)
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction (day 0)
- No. of exposure sites: 2
- Test groups: test substance
- Control group: vehicle
- Site: left and right back
- Frequency of applications: 1
- Concentrations:
0.1 mL FCA (mixed at a ratio of 1+1 in vehicle)
0.1 mL 0.01% test substance (or physiological saline in control)
0.1 mL 0.02% test substance (or physiological saline in control) + FCA (mixed at a ratio of 1+1 in vehicle)
Epicutaneous induction (day 8)
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: test substance
- Control group: vehicle
- Site: back, same region as for intradermal induction
- Frequency of applications: 1
- Concentrations: 30% test substance (or 50% ethanol in water in control)
- Since the test substance is non-irritating, 0.5 g of 10% SDS (vaseline base) was applied on day 7
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: 0.05 mL of the test substance soaked in the cloth portion of an adhesive plaster for patch test
- Control group: same as test group
- Site: lateral abdomen
- Concentrations: 0.5%, 1%, 3%, 5%, 10%, 30% test substance (w/w)
- Evaluation (hr after challenge): 3h, 24 h, 48 h - Challenge controls:
- yes, vehicle only during induction phase
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%, 1%, 3%, 5%, 10%, 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%, 1%, 3%, 5%, 10%, 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%, 1%, 3%, 5%, 10%, 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%, 1%, 3%, 5%, 10%, 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%, 1%, 3%, 5%, 10%, 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5%, 1%, 3%, 5%, 10%, 30%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%, 1%, 3%, 5%, 10%, 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5%, 1%, 3%, 5%, 10%, 30%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No.
Any other information on results incl. tables
Reading | Hours after challenge | Group | Dose level | No. with + reactions | Total no. in group | Clinical observations |
---|---|---|---|---|---|---|
Additional reading | 3 | test group | 0.5%, 1%, 3%, 5%, 10%, 30% | 0 | 10 | No |
Additional reading | 3 | negative control | 0.5%, 1%, 3%, 5%, 10%, 30% | 0 | 5 | No |
No abnormality in the general conditions was observed after induction or challenge during the study period and the animals showed satisfactory body weight increases.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not sensitising
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No. 1272/2008)
DIMAPDO lactate is not a dermal sensitizer in this Guinea pig maximisation test. - Executive summary:
In a dermal sensitization study with DIMAPDO lactate 23 young female Albino Hartley guinea pigs (8 preliminary study, 10 in test group, 5 in control group) were tested using the method of Guinea pig maximization test equivalent to OECD Guideline 406 (1992). No positive control was reported.
Concentration selection was based on a preliminary dose range finding study:
intradermal induction: 0.01% in physiological saline
epicutaneous induction: 30% in 50% ethanol in water
challenge: 0.5%, 1%, 3%, 5%, 10%, 30% in 50% ethanol in water
One day prior to epicutaneous induction the sites were pretreated with SDS to create local skin irritation.
There were no signs of erythema or oedema in any dose group 3, 24 and 48 hours after patch removal. Therefore, DIMAPDO lactateis not a dermal sensitizer in this study.
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