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EC number: 203-367-7 | CAS number: 106-15-0
- 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:
- July 13, 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- (study well documented, followed method comparable to OECD Guideline 406, non-GLP.)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (Pre and post study body weights of the animals are not given.)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Test performed prior to LLNA guideline
Test material
- Reference substance name:
- Amides, coco, N-(hydroxyethyl)
- EC Number:
- 268-770-2
- EC Name:
- Amides, coco, N-(hydroxyethyl)
- Cas Number:
- 68140-00-1
- IUPAC Name:
- Amides, coco, N-(hydroxyethyl)
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material: Coconut monoethanolamide (Cocamide MEA)
- TSIN: T-0358.01
- CAS#: 68140-00-1
- Substance type: Pure active substance
- Physical state: solid flakes
- Appearance: Off-white
- Analytical purity: 96.1% (measured)
- Storage condition of test material: Cool and dry conditions
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- (albino strain)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Murphy breeding laboratories, Inc.
- Age at study initiation: Not Available
- Weight at study initiation: Not Available
- Housing: Singly in wire mesh cages suspended above the droppings
- Diet: Purina Guinea Pig Chow; ad libitum
- Water: Animals were maintained on medicated water containing 4% of sulfaethoxypyridazine ( 6.25% S.E.Z., American Cyanamid) for 4 days. Then they were furnished with non-medicated water; ad libitum.
- Acclimation period: At least 4 days before the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not Available
- Humidity (%): Not Available
- Air changes (per hr): Not Available
- Photoperiod: 12-hour light/ 12-hour dark cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Test animals: 0.4 mL of 30% w/v solution of test substance in distilled water was applied by dermal patches using Parke-Davis bandage
Control animals: no treatment - Day(s)/duration:
- Once a week for three weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.4 mL of 30% w/v solution of test substance in distilled water was applied to all animals (including test and control) by dermal patches using Parke-Davis bandage.
- Day(s)/duration:
- After two weeks of induction phase, animals were once exposed to primary challenge.
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Treatment group: 20 animals
Control group: 10 animals - Details on study design:
- RANGE FINDING TESTS: 4 additional guinea pigs were treated on their backs with each of the four different concentration (30, 15, 8 and 4% w/v solutions) in distilled water to determine the highest non-irritating concentration that can be applied for primary challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1
- Control group: None
- Site: Upper left quadrant of the backs of test animals
- Frequency of applications: Once a week for 3 weeks
- Duration: 6 hours
- Concentrations: 30% w/v solution in distilled water
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after the 3rd induction exposure
- Exposure period: 6 hours under occlusion
- Test groups: 1
- Control group: 1
- Site: Lower left quadrant of the backs of test and control animals
- Concentrations: Coconut monoethanolamide (Cocamide MEA) as a 30% w/v solution in distilled water
- Evaluation: 24 and 48 hours after challenge exposure - Challenge controls:
- 10 animals (previously unexposed) treated with Coconut monoethanolamide (Cocamide MEA) as a 30% w/v solution in distilled water.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- None
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive response
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- (Reactions included 7 grades of ± and 13 grades of 0)
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive response
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- (Reactions included 1 grades of ± and 9 grades of 0)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive response
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- (Reactions included 2 grades of ± and 18 grades of 0)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive response
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- (Reactions included 10 grades of 0)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this Buehler assay, Coconut monoethanolamide (Cocamide MEA) did not induced any positive responses in the test substance treated as well as control animals at primary challenge, hence cocamide MEA is not skin sensitizer in the guinea pig model.
- Executive summary:
The study was performed to assess the skin sensitization potential of Coconut monoethanolamide (Cocamide MEA) by following method comparable to the OECD guideline 406 (Skin Sensitisation).
Male and female Hartley guinea pigs were obtained from Murphy breeding laboratories were used in this study. Animals were singly in wire mesh cages suspended above the droppings and maintained under standard laboratory conditions (12 hours light (artificial)/12 hours dark cycle). Prior to the treatment, animals were acclimatized under laboratory conditions for a minimum period of 4 days. The animals received Purina Guinea Pig Chow and non-medicated water ad libitum.
The test substance was tested at a concentrations of 0% w/v solution in distilled water. Animals were divided into two groups: test substance treatment group (20 animals) and control group (10 animals).
In induction phase, one group of 20 test animals was treated with 0.4 mL of Coconut monoethanolamide (Cocamide MEA) as a 30% w/v solution in distilled water by dermal patches using Parke-Davis bandage. Exposure period was 6 hours and it was repeated weekly for 3 induction exposures. The patch sites were scored for irritation 4-5 hour later. After 2 weeks of last induction exposure, all animals (both test and control) were challenged with 30% w/v solution of Coconut monoethanolamide (Cocamide MEA) in distilled water. The sites were scored after 24 and 48 hours of challenge.
At primary challenge, no positive responses were observed in the test substance treated and control animals. Therefore, it was concluded that Cocamide monoethanolamide (Cocamide MEA) is not a skin sensitizer.
This Buehler assay study is classified as acceptable, and satisfies the guideline requirements of OECD 406 (Skin Sensitization).
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