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EC number: 201-969-4 | CAS number: 90-15-3
- 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
With an EC3 value of 1.3, 1-naphthol is a ‘strong’ sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2001 - August 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot I 6694
- Expiration date of the lot/batch: No Data
- Purity test date: No data
- Purity : > 99%.
- Impurity : there was no evidence to suggest the presence of any significant impurities other than 2-Naphthol at 0.09% w/w and Iron at 2.5 ug/g.
RADIOLABELLING INFORMATION (if applicable)
- Specific activity: 3H
- Locations of the label : methyl Thymidine (Amersham TRA 310, aqueous solution, steriliez 74 GBq/mmol)
- Expiration date of radiochemical substance: No data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (17-20°C) away from direct sunlight
- Stability under test conditions:Yes
- Solubility and stability of the test substance in the solvent/vehicle: Yes
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING : No
FORM AS APPLIED IN THE TEST Suspension - Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles Rivers Deutschland GmBh
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: No data
- Age at study initiation: 7 - 12 weeks
- Weight at study initiation: 14.6 - 25.4 g
- Housing: unique cage number
- Diet (ad libitum): Pelleted standard Kliba 3433
- Water (ad libitum): tap water from Itingen
- Acclimation period: Yes
- Indication of any skin lesions: only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.1 ; 0.25 ; 0.5 ; 1 and 2.5%
- No. of animals per dose:
- 3
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: Yes
- Irritation: No
- Systemic toxicity: No
- Ear thickness measurements: No
- Erythema scores: No
MAIN STUDY
12.5 μl 1-naphthol 0.1, 0.25, 0.5, 1 and 2.5% in 4:1 acetone:olive oil was applied on days 1, 2 and 3 by topical application to the ventral and dorsal surfaces of each ear. Five days after the first topical application, the mice were injected intravenously with 3H-methyl thymidine, five hours later killed and the draining lymph nodes excised and pooled. Single cell suspensions were prepared and the proliferation capacity determined.
ANIMAL ASSIGNMENT AND TREATMENT : No data
TREATMENT PREPARATION AND ADMINISTRATION:
Mice were treated by epidermal topical application to the dorsal surface of each ear lobe (left and right) with different test item concentration. The application volume, 25 µl, was spread over the entire dorsal surface of each ear lobe once daily for three consecutive days.
Five days after the first topical application, the mice were administrated with 250 µl of 87.55 µCi/ml 3HTdR by intravenou injection via a tail vein.
Approximately five hours after treatment with 3HTdR all mice were euthanized by intraperitoneal injection of Narcoren at a dose of at least 2ml/kgbw. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calcultaed in the body weight.
- Positive control results:
- The SI for the positive control was 2.4, 3.7, and 7.0 respectively for the 5, 10 and 25% dilutions
- Parameter:
- SI
- Value:
- ca. 1.4
- Test group / Remarks:
- 0.1%
- Parameter:
- SI
- Value:
- ca. 1
- Test group / Remarks:
- 0.25%
- Parameter:
- SI
- Value:
- ca. 1.2
- Test group / Remarks:
- 0.5
- Parameter:
- SI
- Value:
- ca. 1.5
- Test group / Remarks:
- 1%
- Parameter:
- SI
- Value:
- ca. 8.5
- Test group / Remarks:
- 2.5%
- Key result
- Parameter:
- EC3
- Value:
- 1.3
- Test group / Remarks:
- 2.5 %
- Cellular proliferation data / Observations:
DETAILS ON STIMULATION INDEX CALCULATION
See table 1 - Stimulation Index
EC3 CALCULATION No data
CLINICAL OBSERVATIONS: No clinical signs occured during the study period.
BODY WEIGHTS The body weight of the animals was within the range commonly recored for animals of this strain and age.
MORTALITY No death occured during the study period.- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- 1-Naphthol produced evidence of allergic contact sensitisation in this study at when tested at 2.5%. The EC3 value was calculated to be 1.3. With an EC3 value of 1.3, 1-naphthol is a ‘strong’ sensitizer.
- Executive summary:
12.5 μl 1-naphthol 0.1, 0.25, 0.5, 1 and 2.5% in 4:1 acetone:olive oil was applied on days 1, 2 and 3 by topical application to the ventral and dorsal surfaces of each ear. Five days after the first topical application, the mice were injected intravenously with 3H-methyl thymidine, five hours later killed and the draining lymph nodes excised and pooled. Single cell suspensions were prepared and the proliferation capacity determined.
The Mean stimulation indices was 1.4, 1.0, 1.2, 1.5 and 8.5 respectively for 0.1, 0.25, 0.5, 1.0 and 2.5% w/v concentration. The SI for the positive control was 2.4, 3.7, and 7.0 respectively for the 5, 10 and 25% dilutions.
1-Naphthol produced evidence of allergic contact sensitisation in this study at when tested at 2.5%. The EC3 value was calculated by the SCCS (The SCCP adopted this opinion in April 2008: Opinion on 1 -naphthol SCCP/1123/07) to be 1.3.
Reference
Table 1 - Stimulation Index
Concentration (% w/v) | Stimulation Index |
0.1 | 1.4 |
0.25 | 1.0 |
0.5 | 1.2 |
1.0 | 1.5 |
2.5 | 8.5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
On the basis of the data, 1-naphthol is classified Skin Sens. Cat 1A, H317
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