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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- not specified
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:
- Test item 1
Name: Sodium N-cocoyl-L-alaninate (ACS-12)
Lot No.: 051020-2
Purity: 30.2% (residue: water 69.8%)
Description: liquid (pH 8.4 / 20°C)
Expiration: October 30, 2006
Test item 2
Name: Sodium N-cocoyl-L-alaninate (ACS-12)
Lot No.: 601011
Purity: 30.1% (residue: water 69.9%)
Description: liquid (pH 8.7 / 20°C)
Expiration: January 31, 2007
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 13 weeks
- Weight at study initiation: 2.49 – 2.78 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 24
- Humidity (%): 44 – 79
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- up to 6 days
- Number of animals or in vitro replicates:
- 3 f per lot
- Details on study design:
- The rabbits’ eyes were examined with an ophthalmoscope on the day before application of the test articles. Six animals with no ocular abnormalities, showing regular body weight gain during the quarantine/acclimation period and showing no clinical abnormalities, were chosen and used for the study. At the time of eye examination, the cornea was also examined, using 2% fluorescein sodium aqueous solution, for the presence or absence of abnormalities.
The test items were applied in the conjunctival sac of the left eye of each animal after gently pulling the lower eyelid away from the eyeball. The lid was then gently held together for about 1 second in order to prevent loss of the test article. The right eye, which remained untreated, served as a control.
Animals were observed for clinical signs immediately after application and hourly up to 6 hours after application and once daily thereafter up to day 6.
All animals were weighed on the day of application and on the final day of observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- results for test item 1
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 18.7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- results for test item 2
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 23.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Test item 1
Corneal opacity, conjunctival redness, chemosis and discharge were observed in all (3/3) animals from 1 hour after application. At 24 hours after application, chemosis and discharge diminished but the area of corneal opacity and conjunctival redness increased in 2/3 or all animals and 1/3 animals developed iridal changes. After that, eye irritation reactions were reduced gradually, and iridal changes and chemosis disappeared by 48 hours after application, discharge disappeared by 72 hours after application and corneal opacity disappeared by 96 hours after application. Conjunctival redness was observed only in 1/3 animals at 96 hours after application, but it disappeared by day 5 after application. As other ocular changes, eyelid closure was observed from immediately to 6 hours after application in all animals. The MMTS (Maximum mean total score) was 18.7 at 24 hours after application.
Test item 2
Corneal opacity, conjunctival redness, chemosis and discharge were observed in all (3/3) animals from 1 hour after application. At 24 hours after application, chemosis diminished but the area of corneal opacity and conjunctival redness increased in all animals. After that, eye irritation reactions were reduced gradually, and chemosis disappeared by 48 hours after application and discharge disappeared by 72 hours after application. Conjunctival redness was observed in all animals and corneal opacity was observed in 1/3 animals at 96 hours after application, but they disappeared by day 6 after application. As other ocular changes, eyelid closure was observed in all animals from immediately to 6 hours after application and in 2/3 animals on day 1 after application. The MMTS was 23.3 at 24 hours after application.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- An eye irritation study was conducted in female Japanese White rabbits, in order to examine the irritant effects of two lots of ACS-12 on the eye. 0.1 mL of the diluted test items (5 % w/w) was applied to the left eye of three rabbits for each lot. The cornea, iris and conjunctiva were observed periodically, and irritation reactions were evaluated according to the Draize criteria. Eye irritation reactions were categorized and determined on the basis of the Kay and Calandra method.
Based on the results of this study it was concluded that the two test items should be classified as moderately irritating on the rabbit eye. - Executive summary:
An eye irritation study was conducted in female Japanese White rabbits, in order to examine the irritant effects of two lots of ACS-12 on the eye. 0.1 mL of the diluted test items (5 % w/w) was applied to the left eye of three rabbits for each lot. The cornea, iris and conjunctiva were observed periodically, and irritation reactions were evaluated according to the Draize criteria. Eye irritation reactions were categorized and determined on the basis of the Kay and Calandra method.
Based on the results of this study it was concluded that the two test items should be classified as moderately irritating on the rabbit eye.
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