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EC number: 202-049-5 | CAS number: 91-20-3
- 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
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: Guideline study with acceptable restrictions (limited documentation, low dosing), acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- as of 12 May 1981
- Deviations:
- yes
- Remarks:
- non-occlusive challenge treatment; FCA-water mixture not applied
- Principles of method if other than guideline:
- Guinea pig maximization test reported by Magnusson and Kligman 1969:
Comparative study including naphthalene, Naphthol AS [CAS No. 92-77-3], 2-naphthol [CAS No. 135-19-3] and 2-hydroxy-3-naphthoic acid [CAS No. 92-70-6] - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Naphthalene
- EC Number:
- 202-049-5
- EC Name:
- Naphthalene
- Cas Number:
- 91-20-3
- Molecular formula:
- C10H8
- IUPAC Name:
- naphthalene
- Details on test material:
- - Name of test material (as cited in study report): naphthalene
- Supplier: Katayama Chemical Co., Ltd.
- Molecular formula (if other than submission substance): C10H8
- Molecular weight (if other than submission substance): 128.18
- Substance type: organic
- Physical state: solid
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
body weight 300 - 350 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: paraffin oil and white vaseline (induction) / acetone (challenge)
- Concentration / amount:
- 1 % (i.d induction); 10 % (epicutaneous induction) / 0.1 and 1 % (epicutaneous challenge)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: paraffin oil and white vaseline (induction) / acetone (challenge)
- Concentration / amount:
- 1 % (i.d induction); 10 % (epicutaneous induction) / 0.1 and 1 % (epicutaneous challenge)
- No. of animals per dose:
- 12 treated animals each;
12 in the untreated control group (only the vehicle) - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 (i.d.); 1 (topical)
- Exposure period: 48 h topical
- Test groups: test substance
- Control group: no data (2-naphthol as surrogate)
- Site: shoulder
- Frequency of applications: day 0 (i.d.); day 7 (topical)
- Duration: 7 + 2 days
- Concentrations: First induction:
50 µL i.d. injected in 1 % of test substance in liquid paraffin
50 µL i.d. injected in 1 % of test substance in Freund´s complete adjuvants (FCA)
(Dose: 500 µg each)
Second induction: after 7 d: topically 10 % of test substance in vaseline (volume: no data) for 48 h (closed patch)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: test substance
- Control group: no data (2-naphthol as surrogate)
- Site: flank
- Concentrations: 0.1 and 1 % in acetone
- Dosage volume: 20 µL/cm2
- Dose: 20 and 200 µg/cm2
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- no data
- Positive control substance(s):
- not specified
- Remarks:
- No accepted standard mentioned: 2-naphthol proved the responsiveness of the test system.
Results and discussion
- Positive control results:
- 2-Naphthol: 8/8 animals clearly positive
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 and 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 and 1 %. No with. + reactions: 0.0. Total no. in groups: 24.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 and 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 and 1 %. No with. + reactions: 0.0. Total no. in groups: 24.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Considering the quality of the reporting and the low challenge concentrations of naphthalene used, no firm conclusions can be drawn from this study (ECB 2003).
- Executive summary:
In a poorly reported skin sensitisation study based on the guinea pig maximisation method, a 24-hour open application dermal challenge, with 0.1% or 1% naphthalene in acetone, did not produce any sign of a sensitisation reaction in any of the 24 animals. However no information was provided on the use of positive controls, and at the induction stage no signs of naphthalene-induced irritation were reported at the concentrations examined. However, 2-naphthol was also tested and was positive in all 16 animals tested.
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