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EC number: 204-479-9 | CAS number: 121-54-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February - August 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Benzethonium chloride
- EC Number:
- 204-479-9
- EC Name:
- Benzethonium chloride
- Cas Number:
- 121-54-0
- Molecular formula:
- C27H42NO2.Cl
- IUPAC Name:
- benzyldimethyl(2-{2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy}ethyl)azanium chloride
- Test material form:
- solid: compact
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL
- Name: HYAMINE 1622
- Other ID (batch): Lonza TRCS Number 40109
- Source: Lonza Inc., Annandale, NJ
- Stability: Considered to be stable under conditions of shipment, storage, and use in this study.
- Purity: 99.3%
- Physical description: Fine white powder
- Storage Conditions: Room temperature
- Expiration date: October 26, 1996
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test Animals:
Naive young adult male and female Sprague-Dawley derived albino rats of approximately the same age, weighing 181 to 273 grams on the day of dosing were used. The weight variation of the animals did not exceed ± 20% of the mean weight for each sex. The animals were purchased from Harlan Sprague Dawley, Inc. (Indianapolis, Indiana), a U.S.D.A. licensed supplier.
Housine and Animal Care:
All animals were acclimated to the Laboratory for at least six days before being used. Animals utilized for the range-finding phases were housed in groups of two/sex. Animals utilized for the range-finding phase which were incorporated into the definitive study also were housed in groups of two/sex. Animals utilized for the definitive study were housed in groups of five/sex. The additional animals included to complete the 800 mg/kg dose level were housed in groups of one/sex. All animals were housed in wire mesh suspension cages and were supplied Teklad 4% Mouse/Rat Diet and tap water ad libitum during both the acclimation and test periods except for withholding food (but not water) overnight prior to dosing. Food was withheld from the animals for a minimum of 15 hours, but not more than 18 hours, with exception that food was withheld for approximately 19 to 19.5 hours from animals utilized in the second range-finding screen and approximately 19.5 to 20.25 hours from animals utilized in the definitive study.
The animal room was maintained on a 12-hour light/12-hour dark cycle and at a temperature of 64-78°F and a relative humidity of 40-70%. Food and water were checked daily. There were no contaminants in either the feed or the water that were expected to affect the outcome of this study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Exposure of the rats was divided into two phases: the dose range-finding study phase and the definitive study phase. During both phases, a single dose ofthe test substance as a 10% w/v mixture in distilled water was administered orally by gavage using a stainless steel ball-tip cannula attached to a disposable syringe. Individual doses were calculated using post-fast body weights. Dose volumes for acute oral toxicity tests generally are limited to 10 ml/kg (maximum allowable volume) and 0.1 ml/rat (minimum volume for accurate delivery).
- Doses:
- 1st PRETEST:
- 100, 400 and 800 mg/kg
2nd PRETEST:
- 100, 250, 500 and 800 mg/kg
MAIN TEST:
- 50, 104, 216, 450 and 800 mg/kg - No. of animals per sex per dose:
- 1st & 2nd PRETEST:
- Four animals (two males & two females)
MAIN TEST:
- Ten animals (five males & five females) - Control animals:
- no
- Details on study design:
- An initial range-finding test was conducted with the test item. In this screening, the test substance was administered to three groups of two male and two female Sprague Dawley rats at dose levels of 100, 400 and 800 mg/kg. Based on the results of this screen, dose levels of 50, 104, 216, and 450 mg/kg were selected for the definitive study. During the definitive study, the test item was administered to groups of five male and five female Sprague Dawley rats. Following a single oral administration, the animals were observed for fourteen days. Due to the fact that only 50% mortality was observed in the highest dose group and because there was no clear dose response, additional range-finding work was conducted. During the second dose range-finding screen, the test item was administered to four groups oftwo male and two female Sprague Dawley rats at dose levels of 100, 250, 500 and 800 mg/kg.
- Statistics:
- None
Results and discussion
- Preliminary study:
- 1st PRETEST:
- 100 mg/kg: 0% mortality
- 400 mg/kg: 75% mortality
- 800 mg/kg: 100% mortality
2nd PRETEST:
- 100 mg/kg: 25% mortality
- 250 mg/kg: 0% mortality
- 500 mg/kg: 25% mortality
- 800 mg/kg: 100% mortality
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 295 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 160 - 543
- Mortality:
- DOSE LEVELS:
- 50 mg/kg: 20%
- 104 mg/kg: 20%
- 216 mg/kg: 10%
- 450 mg/kg: 50%
- 800* mg/kg: 100%
* Represents the animals from both dose range-finding screens and the additional animals included to complete this dose level. - Clinical signs:
- other: Treatment related clinical signs were observed at all levels tested: - 50 mg/kg: slightly sluggish, gasping and/or wheezing breathing, red stains on muzzle, fecal stains - 104 mg/kg: slightly sluggish, gasping and/or wheezing breathing, red stains on muzz
- Gross pathology:
- The gross necropsy findings in the animals that died during the observation period included signs of gastrointestinal irritation and signs typically found in agonal animals. The findings included: small amount of a dried red material on muzzle, lungs pale in color, stomach distended with gas and contained a moderate amount of a watery yellow brown feed-like pastel, small areas of intestines appeared reddened, lungs reddened, liver and spleen mottled, fecal stains, kidneys pale and congested, intestines yellow in color and contained a viscous yellow gel-like material, lungs motted, abdominal cavity contained a small amount of a clear red fluid, stomach with a watery yellow brown feed-like paste, areas of intestines hemorrhagic, intestines contained a viscous red fluid. No necropsy findings were noted in animals that survived until the end of the test.
Any other information on results incl. tables
The overall response observed in the two dose range-finding screens and in the definitive study showed that the dose response below 500 mg/kg was very shallow and that nothing would be gained by dosing additional animals at dose levels between 500 and 800 mg/kg. Therefore, two additional animals were dosed with the test item at 800 mg/kg. Both of these animals died following test substance administration. The data from these two animals were combined with the data from the 800 mg/kg dose levels in the two dose range-finding screens and used as the highest dose level in the definitive study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The oral LD50 value on rats was calculated to be 295 mg/kg with 95% Confidence Limits of 160 and 543 mg/kg. The test item is therefore classified as orally toxic, Cat. 3.
- Executive summary:
This study was performed in accordance with EPA test guideliens no. 798.1175 to determine an estimated oral median lethal dose (LD50). In all phases of this study, the test item was administered as a 10% w/v mixture in distilled water. The study was designed to satisfy EPA Pesticide Assessment. An initial range-finding test was conducted. In this screen, the test substance was administered to three groups of two male and two female Sprague Dawley rats at dose levels of 100, 400 and 800 mg/kg. Due to unclear results, additional range-finding work was conducted. During the second dose range-finding screen, the test item was administered to four groups oftwo male and two female Sprague Dawley rats at dose levels of 100, 250, 500 and 800 mg/kg. Based on the results of the screening studies, dose levels of 50, 104, 216, and 450 mg/kg were selected for the definitive study. Four groups of five male and five female Sprague Dawley rats were tested. Following a single oral administration, the animals were observed for fourteen days.
Based on the mortality observed during the definitive study, the oral LD50 value was calculated to be 295 mg/kg with 95% Confidence Limits of 160 and 543 mg/kg. Treatment-related clinical signs were observed at all dose levels tested. All surviving animals appeared normal by Day 8. All surviving animals showed a positive weight gain during the study. The gross necropsy findings in animals that died during the study included signs of gastrointestinal irritation and signs typically found in agonal animals. No gross pathological changes were noted in animals which survived the observation period. Based on the results of this study, the test item needs to be classified as "Acute toxicity, Cat. 3, oral".
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