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EC number: 215-657-0 | CAS number: 1338-02-9
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although the information is only available as a published peer reviewed article which does not mention GLP compliance of the studies enough details are provided to adequately interprete the obtained data.
Data source
Reference
- Reference Type:
- publication
- Title:
- Allegernicity and cross-reactivity of naphthenic acid and its metallic salts in experimental animals
- Author:
- Yamato T., Shimizu M, Noda T.
- Year:
- 2 006
- Bibliographic source:
- Contact Dermatitis, 2006, 54, 25-28
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Although no guideline was followed the methods and results are well described allowing a detailed interpretation of the results.
The most inmportant deviation is the number of animals per group. In this test 5 in stead of the recommended minimum of 10 animals have been used. Next to this also the non-reporting of the performance of the positive control is deviating from the guideline. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Since the LLNA is the preferred method for new in vivo testing, the use of the standard guinea pig tests to obtain new data on the skin sensitisation potential of a substance will be acceptable only in exceptional circumstances and will require scientific justification. However, existing data of good quality that were generated before 10 May 2017, or for which the study was initiated before 10 May 2017, and derived from such tests are acceptable; and if these tests provide clear results that are adequate for classification, even when a conclusion on potency (Cat. 1A or not) cannot be drawn, they will preclude the need for further in vivo testing.
Test material
- Reference substance name:
- Naphthenic acids
- EC Number:
- 215-662-8
- EC Name:
- Naphthenic acids
- Cas Number:
- 1338-24-5
- Molecular formula:
- For the acidic (naphthenic) fraction: CnH2n+zO2, where n = carbon number and z = homologous group series number: z = 0 when no ring structures are present, z = -2 when 1 ring is present, z = -4 when 2 rings are present etc. For the non-acidic fraction: not applicable
- IUPAC Name:
- Naphthenic acids, consisting of an acidic (naphthenic) fraction (70-95%) composed mainly of C8-C20 and 0-3 rings and a non-acidic (petroleum) fraction (5-30%), composed mainly of C12-C22, <10% aromatics, with a boiling range of approximately 160-350°C.
- Test material form:
- other: liquid
- Details on test material:
- Chemical obtained from Wako Pure Chemical Industries (Osaka Japan)
Next to naphthenic acid also cobalt naphthenate, copper naphthenate and zinc napthtenate have been investigated using the Guinea pig maximization test.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other:
- Concentration / amount:
- 1%, 25% as induction; 0.5% as challenge dose
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other:
- Concentration / amount:
- 1%, 25% as induction; 0.5% as challenge dose
- No. of animals per dose:
- 5
- Details on study design:
- 6-week-old female Hartley guinea pigs from Japan SLC (Shizuoka, Japan) were used The GPMT was performed as described previously in the literature 5 animals were used for each sensitization group (CuN, CoN, ZnN and Ν A) The first induction dose was set at 1%, while the second induction dose was 25%. 2 weeks after the second induction, 0.1 ml aliquots of the 7 chemicals in vehicles (0.5% in petroleum ether for CuN, CoN. ZnN and NA, 1% in ethanol for C0CI2. CuCL and ZnCU) were applied to a shaved area of the fiank for challenge all at once. 2 D after the challenge, each site was scored according to the criteria of Sato et al. (*). 1 week later, CoN-sensitized animals were further challenged with various concentrations of CoN and C0CI2 for a dose-response study.
* Sato Y. Katsumura Y. Ichikawa H. Kobayashi T. Kozuka T. Morikawa F. Ohta S. A modilied tcchnique of guinea pig testing to identify delayed hypersensitivity allergens. Contact Dermatitis 1981: 7: 225 237. - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not reported
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 4.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- other: not reported
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Althought there are only a limited numer of animals used per group the sensitizing properties of this substance were clearly positive.
- Executive summary:
A GPMT test in 6-week-old female Hartley guinea pigs was performed with Natphenic acids and salts (copper, zin and cobalt naphthenate). The first induction dose was set at 1%, while the second induction dose was 25%. Two weeks after the second induction, 0.1 ml aliquots of the 7 chemicals in vehicles (0.5% in petroleum ether for CuN, CoN. ZnN and NA) were applied to a shaved area of the fiank for challenge. Each site was scored 48 hours after challenge. Napthenic acid resulted in 4/5 animals with clear reactions at 48 hours, therefore it is considered to be sensitizing for skin.
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