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Diss Factsheets
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EC number: 203-657-3 | CAS number: 109-23-9
- 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:
- weight of evidence
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- No clear description of methods, however a reference is made to the original GPMT procedure (Magnusson and Kligman, procedure similar to OECD TG 406)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Multivariate QSAR analysis of a skin sensitization database.
- Author:
- Cronin MT, Basketter DA
- Year:
- 1 994
- Bibliographic source:
- SAR QSAR Environ Res. 1994;2(3):159-79.
- Reference Type:
- publication
- Title:
- The identification of contact allergens by animal assay. The guinea pig maximization test.
- Author:
- Magnusson B, Kligman AM.
- Year:
- 1 969
- Bibliographic source:
- J Invest Dermatol. 1969 Mar;52(3):268-76.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Test was performed according to Magnusson and Kligman (1969), which is also the basis for OECD TG 406
- Principles of method if other than guideline:
- No clear description of methods, however a reference is made to two well described standard procedure (Magnusson and Kligman, GPMT procedure similar to OECD TG 406; Goodwin and Johnson, SIAT test). All non-sensitizers were identified using the GPMT procedure.
MAGNUSSON AND KLIGMAN
Bibliographic source: J Invest Dermatol. 1969 Mar;52(3):268-76.
Name of the method: guinea pig maximization test (GPMT)
Principle of the method:
- Induction procedure: Injections are given intradermally with and without complete Freund's
Adjuvant (The final concentration of the allergen is 5% by weight provided that it can be well tolerated locally and generally) to Albino guinea pigs weighing 300-500 Grams. A row of 3 injections,
six in all, are made on each side as follows: (1) 0.1 ml of the adjuvant without the test agent, (2) 0.1 ml of test agent without adjuvant and (3) 0.1 ml of the test substance emulsified in complete adjuvant. One week later the test agent is applied topically over the injection site (The test agent in petrolatum is spread over a 2 x 4 cm patch of Whatman No. 3MM filter paper in a thick even layer or, if liquid, to saturation. The patch is covered by an overlapping impermeable, plastic adhesive tape. This in turn is firmly secured by elastic adhesive bandage (6.4 cm in width), wound around the torso of the animal. This dressing is left in place for 48 hours) .
- Challenge procedure: The animals are challenged by patch test two weeks later. The test agent is applied on a 2 x 2 cm piece of filter paper in the same fashion as for topical induction. The patch is sealed to the flank for 24 hours under a 4 cm strip.
GOODWIN AND JOHNSON
Bibliographic source: Curr Probl Dermatol. 1985;14:201-7.
Name of the method: Single injection adjuvant test (SIAT)
Principle of the method: the procedure involves a single injection of the test substance in Freund’s complete adjuvant followed 12 days later by challenge using a 6-hour occlude patch. - GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was conducted before the LLNA method became a standard procedure for in vivo skin sensitisation
Test material
- Reference substance name:
- N,N'-methylenedistearamide
- EC Number:
- 203-657-3
- EC Name:
- N,N'-methylenedistearamide
- Cas Number:
- 109-23-9
- Molecular formula:
- C37H74N2O2
- IUPAC Name:
- N,N'-methylenedistearamide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name as cited in the report: methylene distearamide
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300-500 Grams (according to Magnusson and Kligman, 1969)
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- not specified
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- Not specified
- Day(s)/duration:
- 1 day
- Details on study design:
- METHODS AS DECRIBED IN MAGNUSSON AND KLIGMAN, 1969
- Induction procedure: Injections are given intradermally with and without complete Freund's Adjuvant (The final concentration of the allergen is 5% by weight provided that it can be well tolerated locally and generally) to Albino guinea pigs weighing 300-500 Grams. A row of 3 injections, six in all, are made on each side as follows: (1) 0.1 ml of the adjuvant without the test agent, (2) 0.1 ml of test agent without adjuvant and (3) 0.1 ml of the test substance emulsified in complete adjuvant. One week later the test agent is applied topically over the injection site (The test agent in petrolatum is spread over a 2 x 4 cm patch of Whatman No. 3MM filter paper in a thick even layer or, if liquid, to saturation. The patch is covered by an overlapping impermeable, plastic adhesive tape. This in turn is firmly secured by elastic adhesive bandage (6.4 cm in width), wound around the torso of the animal. This dressing is left in place for 48 hours) .
- Challenge procedure: The animals are challenged by patch test two weeks later. The test agent is applied on a 2 x 2 cm piece of filter paper in the same fashion as for topical induction. The patch is sealed to the flank for 24 hours under a 4 cm strip.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: not specified
- Group:
- test chemical
- Dose level:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: not specified
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- other: not specified
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
From the scores obtained in the GPMT, chemicals may be classified qualitatively into one of four groups, i.e. non, weak, moderate or strong sensitisers. The substance under evaluation in this dossier was classified as non sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In this study performed similar to OECD 406, the substance was considered to be non-sensitising.
- Executive summary:
The sensitising potential of the test substance was assessed in a guinea pig maximisation test (GPMT test) performed similar to OECD 406. During the induction procedure the test animals were given a row of 3 injections on each side (six in total) as follows: (1) 0.1 ml of the adjuvant without the test agent, (2) 0.1 ml of test agent without adjuvant and (3) 0.1 ml of the test substance emulsified in complete adjuvant. One week later the test agent is applied topically over the injection site under occlusive conditions for 48 hours. The animals were challenged by patch test two weeks later. The test agent was applied on a 2 x 2 cm piece of filter paper in the same fashion as for topical induction. The patch was sealed to the flank for 24 hours under a 4 cm strip.
In this study, the substance was considered to be non-sensitising.
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