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EC number: 701-068-0 | CAS number: 2156592-58-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- slightly different grading system
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test material has surfactant properties and thus falls out of the applicability domain of the LLNA (see OECD TG 429)
Test material
- Reference substance name:
- Amines, coco alkyl
- EC Number:
- 262-977-1
- EC Name:
- Amines, coco alkyl
- Cas Number:
- 61788-46-3
- IUPAC Name:
- 61788-46-3
- Reference substance name:
- Coco Alkylamines
- IUPAC Name:
- Coco Alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Genamin CC 100 D (coco alkyl amines)
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 304 - 358 g
- Housing: Terluran cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours periodically
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Induction, first stage, intradermal: 0.1%
Induction, second stage, topical: 1%
Challange: 0.5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Induction, first stage, intradermal: 0.1%
Induction, second stage, topical: 1%
Challange: 0.5%
- No. of animals per dose:
- 10 (test item), 5 (control)
- Details on study design:
- RANGE FINDING TESTS:
6 animals for intradermal treatment, two concentrations tested per animal
concentrations: 0.05, 0.1, 0.5, 2.5, 5, 10, 25, 50, and 100%
6 animals for topical treatment, two concentrations tested per animal
concentrations: 0.25 % (24 h); 0.5, 25, and 50% (24 and 48 h)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 7 days (single intradermal), 48 h (topical)
- Test groups: 1
- Control group: 1
- Site: shoulder region
- Frequency of applications: 2
- Duration: 20 days
- Concentrations: 0.1% (intradermal), 1% (topical)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 20
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: left flank
- Concentrations: 0.5%
- Evaluation (hr after challenge): 24, 48, 72 h - Challenge controls:
- Yes
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
- Positive control results:
- Reliability check (not concurrent): The sensitisation rate after application of the positive control substance mercaptobenzothiazole (15 % in vaseline) was 90 %, confirming the reliability of the test system (BSL ID 072728)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
24 h after challange (removing the patch), erythema grade 1 was recorded for 2 out of 10 test animals. After 48 and 72 h, no further signs of irritation were observed. The maximum percentage of animals sensitized was 20%.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Considering the study results of this sensitization test it can be stated that the test item Coco alkyl amines can be regarded as non-sensitizer after
dermal exposure - Executive summary:
In a GLP-compliant OECD TG 406 skin sensitization study according to Magnusson-Kligmann (guinea pig - maximisation test, GPMT), 10 female guinea pigs + 5 control animals (strain Dunkin-Hartley) were treated with coco alkylamine ("Genamin CC 100 D", technical grade, purity 99.9%, liquid) using cotton seed oils as a vehicle. Based on the results of a pretest, a test substance concentration of 0.1% was used for intradermal induction (0.1 mL), followed by a 1% concentration at epidermal induction. Challenge was performed using a 0.5% substance concentration. For epidermal treatments, patches were loaded with 0.5 mL. In contrast to results of the pretest, no dermal irritation was observed after epidermal induction. After challenge treatment, 2/10 animals showed grade 1 erythema at the 24h reading (positive rate = 20%). One out of these positive animals showed scaling after 48 and 72h. Considering the reported data of this sensitization test it can be stated that the test item Coco alkyl amines caused slight reactions at the tested concentration in 2 out of 10 animals identified as sensitization. However, according to the EC criteria Coco alkyl amine does not classify as skin sensitizer as the sensitization rate was 20%.
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