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EC number: 202-226-7 | CAS number: 93-18-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological Tests on Flavouring Matters
- Author:
- B. L. Oser,
- Year:
- 1 965
- Bibliographic source:
- Fd Cosmet. Toxicol.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Subchronic toxicity study was performed to determine the toxic nature of test substance
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl 2-naphthyl ether
- EC Number:
- 202-226-7
- EC Name:
- Ethyl 2-naphthyl ether
- Cas Number:
- 93-18-5
- Molecular formula:
- C12H12O
- IUPAC Name:
- 2-ethoxynaphthalene
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: β-Naphthyl ethyl ether
- Molecular formula: C12H12O
- Molecular weight: 172.226 g/mol
- Subsatnce type: Organic
- Physical state: Solid
- Purity: No data
Test animals
- Species:
- rat
- Strain:
- other: FDRL
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation:
59.54±1.5gm(Males) 58.0±1.6gm(females)
- Fasting period before study:No data
- Housing:Animals were housed individually in wiremesh cages.
- Diet (e.g. ad libitum): nutritionally adequate basal ration (Purina Laboratory Chow) ad libitum
- Water (e.g. ad libitum): fresh water ad lib
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Cotton seed oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: β-Naphthyl ethyl ether was diluted in cotton-seed oil in a concentration sufficient to provide the predetermined dosage in 2% of the diet. The oil solutions were incorporated into a nutritionally adequate basal ration at dose levels of 5.1 mg/kg bw/day in males and 5.7 mg/Kg bw/day in females.
DIET PREPARATION-No data
- Rate of preparation of diet (frequency): Biweekly
- Mixing appropriate amounts with (Type of food): Nutritionally adequate basal ration (Purina Laboratory Chow)
- Storage temperature of food: No data
VEHICLE-No data
- Justification for use and choice of vehicle (if other than water): Cotton seed oil
- Concentration in vehicle: 5.1 mg/kg for males and 5.7 mg/kg for females
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 mg/kg bw/day (nominal)
- Remarks:
- Expected dose (Male/female)
- Dose / conc.:
- 5.1 mg/kg bw/day (actual dose received)
- Remarks:
- Males
- Dose / conc.:
- 5.7 mg/kg bw/day (actual dose received)
- Remarks:
- Females
- No. of animals per sex per dose:
- Total: 60 (15 males and 15 females)
0 mg/Kg bw: 15 males and 15 females
5.1 mg/Kg: 15 males
5.7 mg/Kg: 15 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Single dosage levels for each substance were derived from the total estimated daily intake, calculated on a mg/kg body weight basis assuming 50 kg as the average body weight, and multiplying by 100.
- Rationale for animal assignment (if not random):No data
- Rationale for selecting satellite groups: No data
- Post-exposure recovery period in satellite groups: No data
- Section schedule rationale (if not random): No data - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Not specified
- Time schedule: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: No data
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: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD EFFICIENCY: Not specified
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study):Not specified
- Time schedule for examinations: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at 6 week and 12 week
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: 8 rats of each sex at a 6-wk period, and in all rats at 12 wk
- Parameters checked in table [No.?] were examined. Hematocrit, hemoglobin, RBCs, WBCs, Neutrophils, Lymphocytes
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at 6 week and 12 week
- Animals fasted: Not specified
- How many animals: 8 rats of each sex at a 6-wk period, and in all rats at 12 wk
- Parameters checked in table [No.?] were examined. Blood urea nitrogen
URINALYSIS: Not specified
- Time schedule for collection of urine: Not specified
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined. Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Not specified
IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined. Not specified
OTHER: Not specified - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, at autopsy, liver and kidney weights were recorded
HISTOPATHOLOGY: Yes, half the animals in each group were taken for histological examination: liver, kidneys, stomach, small and large intestines, spleen, pancreas, heart, lungs, bone marrow, muscle, brain, spinal cord, bladder, adrenals, thyroid, pituitary, gonads, salivary glands, and lymph nodes. - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 5.1 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant alterations were noted in the treated and control animals
- Remarks on result:
- other: No toxic effect were observed
- Dose descriptor:
- NOAEL
- Effect level:
- 5.7 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant alterations were noted in the treated and control animals
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity
- Critical effects observed:
- no
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for test substance is considered to be 5.1 mg/Kg in males and 5.7 mg/Kg in females respectivley.
- Executive summary:
Repeated dose subchronic toxicity study was performed to determine the toxic nature of test substance.The chemical was dosed to FDRL strain rats at dose levels of 5.1 mg/Kg in males and 5.7 mg/Kg in females for 90 days. Concurrent solvent control was also incorporated in the study. The animals were noted for usual observations (i.e. body weight and food consumption), haematologieal and blood chemical determinations, gross pathology and histopathology respectively. Administration of test substance for 90 days at a level in excess of at least 100 times the maximum estimated daily dietary intake in man evoked no adverse effect on growth, food consumption, haematology, blood chemistry, liver and kidney weights or on gross and microscopic appearance of major organs at autopsy. Hence, the No Observed Adverse Effect Level (NOAEL) for test substance is considered to be 5.1 mg/Kg in males and 5.7 mg/Kg in females.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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