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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1963
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted prior to the implementation of current testing guideline and GLP, however according to a still accepted testing method (Draize, 1944). Basic data were given and thus, the study is considered to be acceptable. 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
- Report date:
- 1963
Materials and methods
- Principles of method if other than guideline:
- The testing method was based on the Draize test as described in Draize et al. (1944), J Pharm and Exp Ther 82. Each of ten guinea pigs received a series of 10 injections of 0.1% test item solution, every other day, in a depilated skin region below the midline of the back. The first injected volume was 0.05 mL, the following injected volumes were 0.1 mL each. After 2 weeks following the last induction injection, challenge was conducted by injection of 0.05 mL of the test solution in the skin of the flank. The injection site was examined for skin reaction after a period of 24 hours following challenge.
- GLP compliance:
- no
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Test in guinea pigs available before it was decided to register the substance.
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:
- Form: Liquid
The study was performed on a commercial product (aqueous solution) as the test item is manufactured and used in a liquid form.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Weight at study initiation: 350 - 450 g
- No further details provided
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 20 days, 10 injections
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 14 days after last induction
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 20 days
- Site: depilated skin region below the midline of the back
- Frequency of applications: injection was done every other day
- Concentrations: 0.1% test item solution
- Injected volume: 0.1 mL, except for the first injection (0.05 mL)
- Reading: skin readings were made at the injection sites, 24 hours after each injection had been done; the skin was examined for diameter, heigh and colour.
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Challenge: done after 2 weeks following the last induction injection
- Site: skin of the flank.
- Concentrations: 0.1% test item solution
- Injected volume: 0.05 mL
- Evaluation (hr after challenge): 24 hours
READING
The application site was examined for diameter, heigh and colour. The readings were compared with those made at the sites of the first injection series (induction). If the reactions after challenge were appreciably more pronounced than those observed during induction, the test item was defined as a sensitizer. The degree of sensitization was considered to be, in part, proportional to the observed increase in skin reaction.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Skin reaction at induction was characterized by a mean diameter of 3.6 mm, a mean height of < 1 mm, and a pink coloration (indicates slight erythema). Reaction after challenge had a mean diameter of 3.5 mm, a mean height of < 1mm, and a pink coloration.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
Sodium lauiminodipropionate, as a 10% aqueous solution, was tested at a concentration of 0.1% for sensitization according to the method of Draize (1944) using ten guinea pigs. Induction consisted of a series of 10 injections of 0.1 mL of test solution, except for the first injection done with 0.05 mL; the injections were done every other day over a period of 20 days. After 2 weeks following the last induction injection, challenge was done by single injection of 0.05 mL of the 0.1% test solution; skin reading was done after 24 hours.
Since no obvious differences were noticed when comparing the skin reaction at induction and that after challenge, sodium lauriminodipropionate was considered not to be a skin sensitizer unter the test conditions used.
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