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Diss Factsheets
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EC number: 238-063-3 | CAS number: 14206-62-3
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
Reasons for read across
The test item is the sodium salt of a naphthoic acid. Therefore, data on the free acid may give an indication on the allegenic potential of the sodium salt, the limitation being differences in irritating properties and the concentrations are suitable for testing.
Studies in Animals
3-Hydroxy-2-naphthoic acid (commercial grade) was sensitising in a modified guinea pig maximization test (Okada et al., 1985). The deviation from the OECD TG 406 was that the epicutaneous challenge was performed under open (and not occlusive) conditions. Since the test gave a positive result, this modification is not considered to compromise the validity and reliability of the test. At challenge, 6 out of 9 animals had positive reactions towards the 1 % preparation in acetone, but did not react towards a 0.1 % preparation, indicating an elicitation threshold between 0.1 and 1%. 3-Hydroxy-2-naphthoic acid (purity 98.5%) was not sensitising in a guinea pig maximization test performed with only 10 animals (challenge concentration 0.25%). Due to the small number of animals in the latter test, it cannot be concluded that 3-hydroxy-2-naphthoic acid is not a sensitizer; however, its potency may be low.
Studies in Humans
In humans, no skin sensitisation was seen when 36 subjects (28 healthy, 8 suffering from dermatitis) were patch-tested (48-hr covered contact) with 1% 3-hydroxy-2-naphthoic acid in petrolatum (Kozuka et al., 1980). Due to the small number of subjects, no final assessemant regarding the sensitising potential of 3-hydroxy-2-naphthoic acid in humans can be drawn from this study.
Conclusion
3-Hydroxy-2-naphthoic acid has a skin sensitisation potential. 3-Hydroxy-2-naphthoic acid (1% in acetone) was a sensitiser in a guinea pig maximization test after open epicutaneous challenge. Patch-tests in 36 humans gave no indication of a sensitising effect, however no conclusions can be drawn from these limited studies in humans regarding the skin sensitisation potential of 3 hydroxy- 2-napthoic acid.
Migrated from Short description of key information:
The free acid was tested for its allergenic potential in several studies in animal and human (OECD SISDS SIAM 19). The substance caused positive reactions in a modified maximization assay (Okada et al, 1985). Another guinea pig maximization assay (Hoechst 1988) and a patch test in human (Kozuka et al 1980) gave no positive results. Due to strong deviations from OECD protocols, the small number of animals or patients, respectively, the data are inconclusive and not suitable for a statement on classification.
Justification for classification or non-classification
The data mentioned above are from secondary sources. Due to strong deviations from OECD protocols, small numbers of animals or patients, respectively, the information are inconclusive and not suitable for a statement of classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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