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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
Endpoint summary
Administrative data
Description of key information
Repeated dose subchronic toxicity study was performed by Oser (1965) to determine the toxic nature of test chemical. 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), haematological 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. The present study is single dose study.The study does not conclude conclude higher dose value. Henceforth it is acceptable to take such low NOAEL .
Repeated inhalation
According to column 2 of REACH Annex VIII, the acute toxicity inhalation study need not be conducted because exposure of humans via inhalation route is not likely taking into account the low vapour pressure of the substance2-Ethoxynaphthalene,which is reported as 0.5182 Pa. Also considering the particle size distribution of the substance the majority of the particle size was determined to be in the range of 150-53 micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical2-Ethoxynaphthaleneis highly unlikely. Therefore this study is considered for waiver.
Repeated dermal
The acute toxicity value for 2-Ethoxynaphthalene (as provided in section 7.2.3) is >5000 mg/kg body weight.The substance was also found to be not irrtating to skin. Also, given the use of the chemical as dye compound; repeated exposure by the dermal route is unlikely. Thus, it is expected that 2-Ethoxynaphthalene shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that 2-Ethoxynaphthalene shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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
- 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
- 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 - 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 - 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
- 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
- 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
- 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
- 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
- Critical effects observed:
- no
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 5.7 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviwed publication
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Data from various peer reviewed publications were reviewed to deteremine the toxic nature of 2-Ethoxynaphthalene (CAS no 93 -18 -5). The summary is as mentioned below:
Repeated dose subchronic toxicity study was performed by Oser (1965) 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), haematological 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.
Supported by other Repeated dose subchronic toxicity study which was performed to determine the toxic nature of test substance . The study was performed on rats by the gavage route of administration. The test chemical was studied at dose levels of 5.0 mg/Kg bw/day. No significant alterations were noted at the mentioned dose level. The No Observed adverse effect level (NOAEL) for test substance is 5.0 mg/Kg bw/day.
Another supporting Repeated dose feeding study which was performed to determine the toxic nature of test substance. 5 weanling rats were dosed at dose level of 2% (approximately 2000 mg/Kg bw) in the diet for 2 months. During the 2 months study period, rats developed cataracts and the chemical was considered to be cataractogenic. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for test substance is < 2000 mg/Kg/day.
In a 28 days repeated dose toxicity study, the effect of test substance was evaluated in male and female Sprague Dawley rats. The test chemical was administered by oral gavage in the concentration of 0, 125, 250 or 500 mg/kg body weight/day. 2 animals died at 500 mg/kg bw as compared to control.Abnormalities such as nasal discharge, red crust around the nostrils was observed in all treatment groups. In addition, a few cases of snuffling, eye lid swelling and hunched back posture were also observed in the treated groups. A significant decrease in body weights in male rats on the first, second and fourth week of treatment and in female rats, a significant decrease in body weight was observed on the first, second and third week of treatment were observed as compared to control. No effects on food and water consumption were observed as compared to control. In addition,In hematology, methyl 2-naphthyl ether resulted in significantly increased platelet count along with decreased MCV, MCH and MCHC levels. Treatment with 250 mg/kg body weight/day resulted in significantly decreased levels of hemoglobin and MCHC in male rats. At 250 mg/kg body weight/day, a significant decrease was noticed in neutrophils along with altered values of MCV in female rats. In clinical chemistry, significantly increased the level of testosterone in the 500 mg/kg body weight/day group in males, as well as it significantly increased the level of estrogen in the 250 mg/kg body weight/day group in females. Significant increased levels in cholesterol, potassium and albumin was also observed. Similarly, Changes in relative and absolute organ weight of spleen, kidney, liver, brain, heart, ovaries and uterus were observed when treated with 125, 250 or 500 mg/kg body weight/day. Nasal discharge, red crust around nostril, perineum wet, bloated stomach, viscous oily secretion was found inside the thoracic cavity. Small white solid mass slightly firm in consistency floating inside the urinary bladder was observed. However, due to adaptive metabolic and physiological changes, anoxic/ hypoxic conditions during anesthesia and terminal sacrifice, these findings were considered to be of no toxicological significance. No remarkable changes observed in control and the 500 mg/kg body weight/day-treated animals. A few microscopic findings observed in 500 mg/kg body weight/day-treated animals included collapsed lung with focal inflammation, focal fatty change and excess of lymphocytes in liver, inflammation in small intestine, reactive spleen and excess of mucous in colon. Since the histopathological changes were not observed in 125 mg/kg bw and these findings were also observed in the control animals. Hence, NOAEL was considered to be 125 mg/kg bw when Sprague Dawley male and female rats were exposed daily to test substance by oral route for 28 days.
In repeated toxicity study of test material was performed according OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents). Male and female Crl: CD(SD) of 4 weeks old were used in study. Test material dissolved in corn oil in dose concentration0, 20, 100, 500 mg/kg bw/day and administered in dose volume 10ml/kg by oral gavage route.10 animals/sex/dose for 0 and 500 mg/kg bw/day (5 animals/sex/dose were used as the recovery group). 5 animals/sex/dose for 20 and 100 mg/kg bw/day. All males and females were observed at least three times a day during the administration period and the recovery period. Body weights were measured on days 1, 4, 8, 11, 15, 18, 22, 25 and 28 of administration period and on days 1, 4, 8, 11 and 14 of recovery period. Food consumption of all rats were measured on days 1, 8, 15, 22 and 28 of administration period and on days 1, 8 and 14 of administration. Pathological examinations were performed for all animals and the examination items consisted of organ weight measurements, macroscopic examination and histopathologic examination. The No Observed Adverse Effect Level (NOAEL) was considered to be 100 mg/Kg/day for male and female. When male and female rats were treated with test material orally for 28 days.
Based on the available data summarized, 2-Ethoxynaphthalene (CAS no 93 -18 -5) is not likely to classify as a toxicant upon repeated exposure by oral route of adminsitration.
Repeated inhalation
According to column 2 of REACH Annex VIII, the acute toxicity inhalation study need not be conducted because exposure of humans via inhalation route is not likely taking into account the low vapour pressure of the substance2-Ethoxynaphthalene,which is reported as 0.5182 Pa. Also considering the particle size distribution of the substance the majority of the particle size was determined to be in the range of 150-53 micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical2-Ethoxynaphthaleneis highly unlikely. Therefore this study is considered for waiver.
Repeated dermal
The acute toxicity value for 2-Ethoxynaphthalene (as provided in section 7.2.3) is >5000 mg/kg body weight.The substance was also found to be not irrtating to skin. Also, given the use of the chemical as dye compound; repeated exposure by the dermal route is unlikely. Thus, it is expected that 2-Ethoxynaphthalene shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that 2-Ethoxynaphthalene shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Justification for classification or non-classification
Based on above annotation and CLP criteria , 2-Ethoxynaphthalene (CAS no 93 -18 -5) is not likely to classify as a toxicant upon repeated exposure by oral,dermal and inhalation route of administration.
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