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Diss Factsheets
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EC number: 939-647-7 | CAS number: 1474044-68-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1963
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The test was conducted according to an accepted testing procedure (Draize test). However, only few data on the testing and results were given, and no details on individual scorings were provided in the document. Thus, the data are insufficient for scoring evaluation according to current criteria, and no assessment for classification purpose is feasible. Nevertheless, the data give some evidence of eye irritation. The study was performed on an analogue substance (for justification of read-across, please refer to the corresponding assessment report in Section 13).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 963
Materials and methods
- Principles of method if other than guideline:
- The test conduct was based on the Draize Test (Draize et al. J Pharm and Exp Ther 82, 1944) according to the Federal Register - Code of the Federal Regulations, Part 191, Chapter I, Title 21, reprinted from Federal Register of August 12, 1961, 26 F.R. 7333.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- EC Number:
- 239-032-7
- EC Name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- Cas Number:
- 14960-06-6
- IUPAC Name:
- Sodium Lauriminodipropionate
- Test material form:
- other: liquid
- Details on test material:
- - Common name : Sodium lauriminodipropionate
- For more details, see below the Confidential details for test material
Constituent 1
- Specific details on test material used for the study:
- The study was performed on a commercial product (aqueous solution) as the test item is manufactured and used in a liquid form.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- other: untreated contralateral eye
- Amount / concentration applied:
- a 5% solution of the test item was used.
- Duration of treatment / exposure:
- Single instillation into the conjunctival sac of the eye without washing out
- Observation period (in vivo):
- 7 days
Reading time points: 24, 48, 72 and 96 hours, and on day 7 - Number of animals or in vitro replicates:
- no data reported
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.8
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 5.8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Unconventional scoring method
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.6
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- - Following scoring values were reported:
. Cornea: 3.0 at 24 h, 0.8 at 48 h and 0 at 72 h
. Iris: 5.8 at 24 h, 2.5 at 48 h and 0 at 72 h
. Conjunctivae: 2.6 at 24 h, 0 at 48 h and 0 at 72 h (no distinction was made between redness and chemosis)
The values reported for the iris (i.e. 5.8 and 2.5) indicate that the scoring as performed in the study was not in accordance with scoring procedure as currently needed and conducted for purpose of assessment of the eye irritation potential of the test item.
Nevertheless, since scores of 0 were reported at reading time point 72 h for each of cornea, iris and conjunctivae, full reversibility seems to be achieved at that time point.
Applicant's summary and conclusion
- Interpretation of results:
- other: not possible accoring to current criteria
- Conclusions:
- Eye reactions were noticed at 24 and 48 h, but recovery seemed to be achieved at 72 h post-instillation.
- Executive summary:
A test solution containing 5% of sodium lauriminodipropionate was tested in rabbits for eye irritation according to the Draize test as described in the Federal Register - Code of the Federal Regulations, Part 191, Chapter I, Title 21, reprinted from Federal Register of August 12, 1961, 26 F.R. 7333.
- Following scoring values were reported:
. Cornea: 3.0 at 24 h, 0.8 at 48 h and 0 at 72 h.
. Iris: 5.8 at 24 h, 2.5 at 48 h and 0 at 72 h.
. Conjunctivae: 2.6 at 24 h, 0 at 48 h and 0 at 72 h (no distinction was made between redness and chemosis).
The values reported for the iris (i.e. 5.8 and 2.5) indicate that the scoring as performed in the study was not in accordance with scoring procedure as currently needed and conducted for purpose of assessment of the eye irritation potential of the test item.
Nevertheless, since scores of 0 were reported at reading time point 72 h for each of cornea, iris and conjunctivae, full reversibility seems to be achieved at that time point.
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