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EC number: 290-475-2 | CAS number: 90170-42-6
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 24 September -02 Oktober 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across from sodium salt, sodium β-Alanine, N-C8-18-alkyl derivs. EC 305-318-6 The study was performed in compliance with GLP and according to OECD guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate
- EC Number:
- 305-318-6
- EC Name:
- Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate
- Cas Number:
- 94441-92-6
- IUPAC Name:
- sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material :
- Physical state: liquid (colorless)
- Analytical purity: confidential information
- Composition of test material, percentage of components: confidential information
- Lot/batch No.: confidential information
- Expiration date of the lot/batch: confidential information
- Storage condition of test material: Room temperature, in the dark, container: plastic flask.
- Other: Date received 10 September 2007
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Linxe
- Age at study initiation: 18 weeks
- Weight at study initiation: 3.20-3.84 kg
- Housing: Individual box
- Diet (e.g. ad libitum): ad libitium
- Water (e.g. ad libitum): ad libitium
- Acclimation period: 5 days
- Other: Albino rabbits (male)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25 °C
- Humidity (%): 36-70 %
- Photoperiod (hrs dark / hrs light): (12/12)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0,1 mL of test item was instilled into conjunctival sac of one eye, the other eye remained untreated as control.
- Duration of treatment / exposure:
- Single dose.
- Observation period (in vivo):
- 1, 24, 48, and 72 hours following treatment and daily thereafter up to 8 days after treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: In accordance with OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- ca. 1.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The conjunctiva reactions observed during the study have been moderate, and totally reversible in the three animals: a moderate redness, noted 24 hours after the test item instillation and totally reversible between day 6 and day 8, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between day 3 and day 6.
- Other effects:
- No other effects were observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The eye irritating potential of Amphotensid EH was investigated in an acute eye irritation study, which was performed according to OECD 405 and under GLP conditions. Based on the results, the test item does not need to be classified according to the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008, under the conditions of this study.
- Executive summary:
The eye irritating potential of Amphotensid EH was investigated in an acute eye irritation study, which was performed according to OECD 405 and under GLP conditions. Three male albino New Zealand White rabbits were administered a single ocular dose of 0.1 ml of the test substance and observed up to eight days after instillation. Moderate conjunctiva reactions (redness and chemosis) were observed, which were totally reversible within 8 days. Based on these results, the test item does not need to be classified according to the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008, under the conditions of this study.
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