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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
Key value for chemical safety assessment
Effects on fertility
Description of key information
A prenatal toxicity study is available.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
The maternal NOEL of the 1-naphthol was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Remarks:
- The 1998 study is a Dose Range Finding study where the three doses are selected
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Test substance RE-1141.02 (equivalent to 1-naphthol) ; Batch 02 (crystal)
- Expiration date of the lot/batch: No Data
- Purity test date: No Data
- Purity Test : 99.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: Yes
- Solubility and stability of the test substance in the solvent/vehicle: Yes
TREATMENT OF TEST MATERIAL PRIOR TO TESTING No
FORM AS APPLIED IN THE TEST : liquid - Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CRL:CD(SD)BR VAF/Plus
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc, Portage, Michigan, USA
- Age at study initiation: 73 days
- Weight at study initiation: 224 - 267 g (female) and 513 - 872 g (male)
- Fasting period before study: No data
- Housing: individual
- Diet :ad libitum (certified rodent diet#5002 PMI Nutrition International, St Louis, Missouri, USA) and analyses were routinely performed by the feed supplier.
- Water: ad libitum (tap water -reverse osmosis membrane) and the processed water is analyzed twice annually.
- Acclimation period: Yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26°C
- Humidity (%): 30% to 70%
- Air changes (per hr): ten changes per hour
- Photoperiod (hrs dark / hrs light): 12h light /12h dark - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water): -
- Concentration in vehicle: 20, 100, 400 mg/kg/day
- Amount of vehicle (if gavage): 10 ml/kg bw adjusted daily on the basis of the individual body weight
- Lot no.: 32H0921
- Purity: No informaton of any potential contaminants (that would interfere with the results of this study.) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- All levels (first and last preparation). All the conclusions indicate that the formulations were prepared correctly and are homogeneous.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1/1
- Length of cohabitation: max 5 days
- Further matings after two unsuccessful attempts: No Data
- Verification of same strain and source of both sexes No data
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 10 days (DG 7 to DG 17)
- Frequency of treatment:
- Once daily on days 7 through 17 of presumed gestation
- Duration of test:
- Approximately 4 weeks
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25 per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: on the basis of a dosage-range study
- Other:
The rats were intubated once daily at approximately the same time each day. The oral (gavage) route was selected for use because in comparison with the dietary route, the exact dosage can be accurately administered; and it allows the systemic toxic potential of the test article to be fully characterized.
All rats were sacrificed by carbon dioxide asphyxiation on DG 20 - Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice each day of the study. The rats were also examined for clinical observations of effects of the test article, abortions, premature deliveries and deaths before and approximately 30 minutes (± 10 minutes) after dosage (DGs 7 through 17) and once daily during the postdosage period (DGs 18 through 20)
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice each day of the study. The rats were also examined for clinical observations of effects of the test article, abortions, premature deliveries and deaths before and approximately 30 minutes (± 10 minutes) after dosage (DGs 7 through 17) and once daily during the postdosage period (DGs 18 through 20)
BODY WEIGHT: Yes
- Time schedule for examinations: recorded on D0 and daily during the dosage and post-dosage periods.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes (DG 0, 7, 10, 12, 15, 18 and 20)
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day #20
- Organs examined: thoracic, abdominal and pelvic viscera - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes[all per litter]
- Soft tissue examinations: Yes: [half per litter]
- Skeletal examinations: Yes: [half per litter]
- Head examinations: No - Statistics:
- Clinical observation and other proportion data were analyzed using the Variance Test for Homogeneity of the Binomial Distribution
Continuous data were analyzed using Bartlett's Test of Homogeneity of Variances and the Analysis of Variance when appropriate.when appropriate. If the Analysis of Variance was significant (p≤0.05), Dunnett's Test was used to identify the statistical significance of the individual groups. If the Analysis of Variance was not appropriate, the Kruskal-Wallis Test was used, when lessthan or equal to 75% ties were present. In cases where the Kruskal-Wallis Test was statistically significant (p≤0.05), Dunn's Method of Multiple Comparisons was used to identify the statistical significance of the individual groups. If there were greater than 75% ties, Fisher's Exact Test was used to analyze the data.
Count data obtained at Caesarean-sectioning of the dams were evaluated using the procedures described above for the Kruskal-Wallis Test - Historical control data:
- Yes (june 1995 - June 1997) - 97 studies
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically significant numbers of rats (p<0.01) in the 400 mg/kg bw/day dosage group had excess salivation, dilated pupils, decreased motor activity, ataxia, impaired righting reflex, lacrimation, lost righting reflex, lethargy, red, brown or orange perioral substance, urine stained abdominal fur, rales, chromorhinorrhea, twitches, body jerks and brown perinasal substance.
Additionally, dilated pupils, lacrimation, brown perioral substance and chromorhinorrhea occurred in one to five rats in the 100 mg/kg bw/day dosage group (p<0.05); the incidence of chromorhinorrhea was statistically significant.
All other adverse clinical signs were considered unrelatated to the test article. - Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gains were significantly reduced for the entire dosage period (DG 7 to 18), the gestation period after the initiation of dosing (DG 7 to 20) and the entire gestation period (DG 0 to 20) in the 400 mg/kg bw/day group.
Maternal body weights were significantly reduced (p<0.05 or p<0.01) on DG 10 and 12 through 20, compared to the control group.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Absolute (g/day) and relative (g/kg/day) feed consumption values were significantly reduced (p≤0.05 or p≤0.01) on DGs 7 to 10, 10 to 12, 12 to 15 and 15 to 18 in the 400 mg/kg/day dosage group, as compared with the control group values. Significantly increased (p≤0.01) relative feed consumption values occurred in the 400 mg/kg/day dosage group during the postdosage period (DGs 18 to 20), rebound phenomena that commonly occur in these types of studies. Reflecting these events, the 400 mg/kg/day dosage group had significantly reduced (p≤0.01) absolute and relative feed consumption values for the entire dosage period (calculated as DGs 7 to 18), the entire period of gestation after the initiation of dosing (DGs 7 to 20), and the entire gestation period (DGs 0 to 20; absolute only). Feed consumption values were unaffected by the 100 mg/kg/day dosage of the test article.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not examined
- Description (incidence and severity):
- No gross lesions were identified at necropsy that was considered treatment related.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- not examined
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- not examined
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 20 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- Key result
- Abnormalities:
- not examined
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Average foetal body weights were reduced by 4% as compared to controls in the 400 mg/kg bw/day dosage group; these reductions were significant (p<0.05) for total and female foetal body weights.
This decrease in fetal weight, although within historical ranges of the Testing Facility, may have been treatment-related because there was evidence of maternal toxicity at this same dosage (significant decreases in maternal weight and feed consumption values).However, no other Caesarean-sectioning or litter parameters were affected by administration of the test article to the dams at dosages as high as 400 mg/kg/day. This includes a lack of typical changes in skeletal ossification that are indicative of developmental delay and which would have been expected to accompany significant fetal weight decrements.
Furthermore, the magnitude of the weight reduction is at the limit of statistical ascertainment for this endpoint on this study (typically 5%).
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A depressed eye bulge occurred in three 100 mg/kg/day dosage group fetuses from two litters (4954-10; 4971-6,-12). Visceral examination of these fetuses revealed associated microphthalmia of the left or right eye. The significant increase (p≤0.01) in the fetal incidence of this malformation was considered unrelated to the test article because: 1) it was not dosage-dependent; and 2) the litter incidence, the more relevant parameter(1), was not significant.
- Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The umbilical artery descended to the left of the urinary bladder in one control group fetus and four 100 mg/kg/day dosage group fetuses. The significant increases (p≤0.01) in the fetal and litter incidences of this alteration were considered unrelated to the test article because they were not dosage-dependent. No additional alterations occurred in these fetuses.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 400 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- changes in litter size and weights
- Key result
- Abnormalities:
- not examined
- Key result
- Developmental effects observed:
- no
- Conclusions:
- The maternal NOEL of 1-naphthol was 20 mg/kg bw/day because of a significant incidence of chromorhinorrhea, dilated pupils and lacrimation of some animals in the 100 mg/kg bw/day group. The developmental NOAEL was set at 400 mg/kg bw/day, the highest dose applied.
- Executive summary:
Twenty-five pregnant female rats were assigned to each of four dosage groups. The test substance or aqueous 0.5% carboxymethylcellulose (control) was administered via gavage once daily on days 7 through 17 of presumed gestation. Vehicle and dosages of 20, 100, and 400 mg/kg bw/day were administered daily. Animals were observed for viability at least twice each day of the study. Body weights were recorded daily during the dosage and postdosage periods and feed consumption values were recorded. All rats were sacrificed by carbon dioxide asphyxiation on day 20, and a gross necropsy of the thoracic, abdominal and pelvic viscera was performed. The number of corpora lutea in each ovary was recorded. The uterus of each rat was examined for pregnancy, number and distribution of implantations, live and dead foetuses and early and late resorptions. Each foetus was identified, weighed and examined for sex and gross external alterations. Approximately one-half of the foetuses in each litter were examined for soft tissue alterations and the remaining foetuses in each litter examined for skeletal alterations.
Results: No deaths, abortions or premature deliveries occurred during this study. Statistically significant numbers of rats in the 400 mg/kg bw/day dosage group had excess salivation, dilated pupils, decreased motor activity, ataxia, impaired righting reflex, lacrimation, lost righting reflex, lethargy, red, brown or orange perioral substance, urine stained abdominal fur, rales, chromorhinorrhea, twitches, body jerks and brown perinasal substance. Additionally, dilated pupils, lacrimation, brown perioral substance and chromorhinorrhea occurred in one to five rats in the 100 mg/kg bw/day dosage group; the incidence of chromorhinorrhea was statistically significant. No gross lesions were identified at necropsy that was considered treatment related. Body weight gains and absolute and relative feed consumption values were significantly reduced for the entire dosage period in the 400 mg/kg bw/day group. Maternal body weights were significantly reduced compared to the control group. Average foetal body weights were reduced by 4% as compared to controls in the 400 mg/kg bw/day dosage group; these reductions were significant for total and female foetal body weights. No other Caesarean-sectioning or litter parameters were affected by exposure to the test substance to the dams at dosages as high as 400 mg/kg bw/day. (No typical changes in skeletal ossification those are indicative of developmental delay and which would have been expected to accompany significant foetal weight decrements). The slight foetal body weight reduction might be influenced by maternal toxicity.
Reference
Summary of Fetal Alterations
In the 0 (Vehicle), 20, 100 and 400 mg/kg/day dosage groups, litters with fetuses with any alteration numbered 5 (21.7%), 3 (12.0%), 11 (44.0%) and 9 (36.0%), respectively. The numbers of fetuses with any alteration observed were 8 (2.4%), 3 (0.9%), 17 (4.6%)* and 14 (3.7%), and the percentages of fetuses per litter with any alterations were 2.64%, 1.57%, 4.43% and 3.76% in the four dosage groups, respectively. All fetal alterations were considered unrelated to the test article because the incidences: 1) were not dosage-dependent; and/or 2) were within the ranges observed historically at the Testing Facilitya. The statistically significant increase (p≤0.05) in fetuses with any alterations in the 100 mg/kg/day dosage group reflected the significantly increased (p≤0.01) number of fetuses and litters with umbilical artery descending to the left of the urinary bladder, the number of fetuses with microphthalmia and the number of fetuses with hypoplastic ribs.
* Significantly different from the vehicle control group value (p≤0.05).
Caesarean-Sectioning and Litter Observations summaries
Caesarean-sectioning observations were based on 23 (92%), 25 (100%), 25 (100%) and 25 (100%) pregnant rats with live litters in the four respective dosage groups. One litter in the 20 mg/kg/day dosage group (4939) consisted of only four conceptuses. Because such occurrences can abnormally skew the distribution of the data(19), statistical analyses were made without the values for this dam and litter.
Average fetal body weights were reduced by 4% as compared to controls in the 400 mg/kg/day dosage group; these reductions were significant (p≤0.05) for total and female fetal body weights. This decrease in fetal weight, although within historical ranges of the Testing Facilitya, may have been treatment-related because there was evidence of maternal toxicity at this same dosage (significant decreases in maternal weight and feed consumption values). However, no other Caesarean-sectioning or litter parameters were affected by administration of the test article to the dams at dosages as high as 400 mg/kg/day. This includes a lack of typical changes in skeletal ossification that are indicative of developmental delay and which would have been expected to accompany significant fetal weight decrements. Furthermore, the magnitude of the weight reduction, 4%, is at the limit of statistical ascertainment for this endpoint in this study (typically 5%). The litter averages for corpora lutea, implantations, litter sizes, live fetuses, early and late resorptions, percent resorbed conceptuses, and percent live male fetuses were comparable among the four dosage groups and did not significantly differ. No dam had a litter consisting of only resorbed conceptuses, and there were no dead fetuses; all placentae appeared normal.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 400 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klimisch 1
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
On the basis of the data, the 1-naphthol is not classified.
Additional information
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