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EC number: 290-478-9 | CAS number: 90170-45-9
- 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:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 07-1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed in 2006
Test material
- Reference substance name:
- L-Alanine, N-coco acyl derivs., sodium salts
- EC Number:
- 290-478-9
- EC Name:
- L-Alanine, N-coco acyl derivs., sodium salts
- Cas Number:
- 90170-45-9
- Molecular formula:
- RHNNaO3
- IUPAC Name:
- L-Alanine, N-coco acyl derivs., sodium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name: Sodium Cocoyl-L-Alaninate (ACS-12)
Lot No.: 601011
Description: liquid
Purity: 30.1 % (as active ingredient)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Original study in Japanese
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % (w/w)
- Day(s)/duration:
- day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10% (w/w)
- Day(s)/duration:
- day 8 (over 48 hours)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 2.5 and 0.5 % (w/w)
- Day(s)/duration:
- day 22 (over 24 hours)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Group 1 (vehicle controls): 5 f
Group 2 (test item): 10 f - Details on study design:
- During the study the guinea pigs were examined for local skin reactions and general condition.
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
- Positive control results:
- all tested animals reacted positive as expected
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: 1st and 2nd reading (24 and 48 hrs after challenge)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 and 2.5 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the given experimental conditions, the test item showed no positive responders and has not to be classified as a sensitizer.
- Executive summary:
The test item was evaluated for skin sensitizing properties in a GLP study performed according to OECD GL 406. 5 female guinea pigs in the negative control group treated with the vehicles and 10 females in the test material group were investigated. After challenge no positive reactions in the test material treated skin sites at both readings were seen. Under the given experimental conditions, the test item showed no positive responders and has not to be classified as a sensitizer.
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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