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EC number: 405-490-3 | CAS number: 613-62-7 BENZYL-2-NAPHTHYLETHER; BETA-NAPHTHYLBENZYLETHER (BON); BNE; BON; NIPAFAX BNE; SENSLON-50; ZO-1
- 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
- Study period:
- July 6 1993 - July 4 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD-Guidline study conducted in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-benzyloxy-naphthalene
- IUPAC Name:
- 2-benzyloxy-naphthalene
- Reference substance name:
- 2-(phenylmethoxy)naphthalene
- EC Number:
- 405-490-3
- EC Name:
- 2-(phenylmethoxy)naphthalene
- Cas Number:
- 613-62-7
- Molecular formula:
- C17H14O
- IUPAC Name:
- 2-(benzyloxy)naphthalene
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): BNE
- Substance type: organic
- Physical state: solid
- Analytical purity: 99.8%
- Lot/batch No.: 20979
- Expiration date of the lot/batch: August 31, 1994
- Stability under test conditions: stable for 7 days at 60 mg/ml in corn oil
- Storage condition of test material: at room temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL-Biological Research Laboratories Ltd., Wölferstrasse 4, CH 4414 Füllinsdorf / Switzerland
- Age at study initiation: 11 weeks
- Weight at study initiation: 185 - 228 g
- Fasting period before study: no
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 40 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The mixtures of the test article and vehicle were prepared daily before administration.
BNE was weighed into a glass beaker on a tared precision balance and the vehicle added (w/v). The mixtures were prepared using a mortar and pestle. During the daily administration period, homogeneity was maintained using a magnetic stirrer.
VEHICLE
- Amount of vehicle (if gavage): 2 ml / kg bw
- Source: Corn oil of specific quality, Siegfried AG, CH 4800 Zofingen / Switzerland. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration, homogeneity and stability of the test article/vehicle mixtures were determined on one occasion before starting the study. Samples were taken immediately after preparation and again 2 hours later. During the dosing period of this study, samples were taken for confirmation of concentration, hommogeneity and stability on one occasion. analyses were performed by the RCC Analytical Chemistry Laboratory using a method supplied by the sponsor.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1.0
- Length of cohabitation: overnight
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from day 6 through to day 15 post coitum.
- Frequency of treatment:
- once daily
- Duration of test:
- On day 21 post coitum, the females were killed by CO2 asphyxiation and the fetuses were removed by Caesarean section.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 1000 mg / kg bw / day
Basis:
actual ingested
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dosages were based on the results of the dose range-finding study.
- Animal assignment: Mated rats were assigned to the different groups on the day of mating using a random algorithm.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on day 21 post coitum
- Organs examined: all internal organs with emphasis upon the uterus, uterine content, position of fetuses in the uterus and number of corpora lutea - 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
- Skeletal examinations: Yes: half per litter
- Soft tissue examinations / Head examinations: Yes: half per litter - Statistics:
- The following statistical methods were used to analyze body weights, food consumption, reproduction and skeletal examination data:
Means and standard deviation of various data were calculated. Univeriate one-way analysis of variance was used to assess the significance of intergroup differences. If the variables could be assumed to follow a normal distribution, the Dunnett-test (many-one t-test), based on a pooled variance estimate, was applied for intergroup comparisons (i.e. single treatment groups against the control group).
The Steel-test (many-one rank test) was applied when the data could not be assumed to follow a normal distribution.
Fisher's Exact test for 2x2 tables was applied if the variables could be dichotomized without loss of information.
Individual values, means, standard deviations and t-statistics were rounded off before printing.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- 2-(phenylmethoxy)naphthalene was adiminstered orally by gavage once daily to mated female Wistar rats at dosages of 100, 300, and 1000 mg/kg body weight/day from day 6 ghrough to day 15 post coitum to assess the effects on embyonic and fetal development.
No test article-related effect on the maternal or fetal organism was noted up to and including the highest dose level of 1000 mg/kg bw/day, which was considered to be the no-observable adverse effect level (NOAEL).
Under the conditions described for this study, 2-(phenylmethoxy)naphthalene did not reveal any teratogenic potential up to and including the highest dose level of 1000 mg/kg bw/day. - Executive summary:
- The purpose of this study was to assess the effects of
2-(phenylmethoxy)naphthalene on embryonic and fetal development in
pregnant Wistar rats.
Each group consisted of 25 mated female rats. 2-(phenylmethoxy)naphthalene was administered orally by gavage once daily from day 6 through to day 15 post coitum, at dose levels of:
Group 1: 0 mg/kg bodyweight/day (vehicle conrol)
Group 2: 100 mg/kg bodyweight/day
Group 3: 300 mg/kg bodyweight/day
Group 4: 1000 mg/kg bodyweight/day
The dosages were based on the results of the dose range-finding study. The dose volume was 2 ml/kg body weight with a daily adjustment to the acutal body weight. Control animals were dosed with the vehicle alone (corn oil).
Females were sacrificed on day 21 post coitum and the fetuses were removed by Caesarean section. the examination of the dams and fetuses was performed in accordance with international recommendations.
Results
Maternal Data
General Tolerability
No animal died before scheduled necropsy. No test article-related clinical symptoms or postmortem findings were noted. Mean daily food consumption, body weight gain and corrected body weight gain (corrected for uteris weight) were unaffected by the treatment with the test article.
Reproduction Parameters
The reproduction parameters of dams showed no test article-related differences to those of the vehicle control dams.
Fetal Data
Evaluation of external examinations (for abnormal findings), visceral examination (Wilson's technique), and skeletal examinations (for abnormal findings and stage of development) showed no test article-related effects.
Sex ratios of all groups compared favorably. Differences noted in mean fetal body weights were considered to be incidental.
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