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EC number: 205-182-7 | CAS number: 135-19-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A well documented study according to OECD and GLP guidelines. In the OECD SIDS on 2-Naphthol (2002) a similar reliability was assigned.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 415 (One-Generation Reproduction Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-naphthol
- EC Number:
- 205-182-7
- EC Name:
- 2-naphthol
- Cas Number:
- 135-19-3
- Molecular formula:
- C10H8O
- IUPAC Name:
- 2-naphthol
- Details on test material:
- purity 99.6 wt %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 5 weeks (males), 10 weeks (females)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% sodium carboxymethylcellulose solution
- Details on mating procedure:
- Mating period: max 3 weeks (1:1, until pregnancy or until three weeks had elapsed).
- Duration of treatment / exposure:
- Exposure period: males: for 10 weeks prior to mating, during the mating period and until the day before necropsy (98 days); females: for 2 weeks prior to mating, during mating and gestation and until day 20 of lactation.
Premating exposure period: Male : 10 weeks / Female : 2 weeks - Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 10; 40; 160 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 25 per sex per dose group.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Pregnant females were allowed to deliver spontaneously and were sacrificed on day 21 of lactation together with their offspring. Test substance was applied until the day before sacrifice.
Examinations
- Maternal examinations:
- Principal organs, pituitary gland, stomach, adrenal glands, testes, epididymides, coagulating glands, seminal vesicles and prostate were isolated and examined. The organs from the control and the high-dose group and all organs with macroscopic abnormalities were processed for histopathological examinations.
Pregnant females were allowed to deliver spontaneously and were sacrificed on day 21 of lactation together with their offspring. Test substance was applied until the day before sacrifice. At necropsy, all females were examined for abnormalities of the principal organs, the uteri were isolated and the number of implantations counted. In addition, pituitary gland, stomach, adrenal glands, ovaries, cervix and vagina were examined. All organs with macroscopic abnormalities were processed for histopathological examinations. - Statistics:
- Frequency/length of estrous cycle, copulation and fertility indices and frequency of offspring with morphological abnormalities were analyzed by Fisher's exact probability test. Differences in histopathological findings, the graded data and total numbers of postitives were analyzed by Mann-Whitney`s U-test and one-tailed Fisher's exact probability test, respectively. Individual data or mean values of each litter were treated as a single sample, and homogeneity of variance of these samples among groups was analyzed using Bartlett's test. When homogeneity of variance was confirmed, one-way analysis of variance was applied to detect significance between groups. If a significant difference was detected, the Dunnett's test was applied for multiple comparisons. When variance was not
homogenous or zero, the Kruskal-Wallis analysis of ranks was applied, and, if significance was detected, the Dunnett's test applied for multiple comparisons.
Significance levels: p=0.01 and 0.05
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
All females showed normal estrous cycle, and all animals performed fertile copulation. No adverse effect of the test substance was observed on pairing days until conception and number of vaginal estrous during the mating period. Though some females in each group did not become pregnant after copulation, 2-naphthol treatment did not affect fertility index. Furthermore, no abnormality was found in delivery, on gestation index and gestation length. According to the authors of the study, 160 mg/kg bw could however suppress nursing behaviour, since 2-naphthol was shown to depress activity in dams.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 other: mg/kg bw
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 160 other: mg/kg bw
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A one-generation reproduction toxicity test on 2-naphthol was performed on Sprague-Dawley male rats. It permitted to identify 2 NOAEL: 10 mg/kg bw for maternal toxicity and > 160 mg/kg bw for teratogenicity.
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