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EC number: - | CAS number: -
- 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
Acute oral toxicity in Rats
Acute dermal toxicity in Rats
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 12, 2017 -January 17,2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- COA attached
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Number of Animals: 5
Sex: Female, nulliparous and non-pregnant.
Species/Strain: Rat/Sprague-Dawley derived, albino.
Age/Body Weight: Young adult (8-11 weeks)/1 45-187 grams at experimental start.
Source: Received from SAGE® Labs on December 7 and 20,2017.
Husbandry
Housing: The animals were singly housed in suspended stainless steel caging, which
confonns to the size recommendations in the most recent Guide for the Care and Use
of Laboratory Animals (Natl. Res. Council, 20 II). Enrichment (e.g., toy) was placed
in each cage. Litter paper was placed beneath the cage and was changed at least
three times per week.
Animal Room Temperature and Relative Humidity Ranges: 19-23°C and 36-60%,
respectively.
Animal Room Air Changes/Hour: 12. Airflow measurements are evaluated regularly
and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 5-19 days
Food: Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was
available ad libitum, except during fasting.
Water: Filtered tap water was supplied ad libitum.
Contaminants: There were no known contaminants reasonably expected to be found
in the food or water at levels which would have interfered with the results of this
study. Analyses of the food and water are conducted regularly and the records are
kept on file at Product Safety Labs. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test substance was administered to the stomach using a stainless steel ball-tipped gavage
needle attached to an appropriate syringe. Following administration, each animal was returned to
its designated cage. Feed was replaced approximately 3-4 hours after dosing. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females received the limit dose 2000 mg/kg bw
- Control animals:
- no
- Details on study design:
- Selection of Animals:
Prior to each dosing, experimentally naive rats were fasted overnight by removing the feed from
their cages. During the fasting period, the rats were examined for health and weighed (initial).
Five healthy, naive female rats (not previously tested) were selected for test.
Preparation of Test Substance:
The test substance was administered as received and mixed well prior to use.
Dose Calculations:
Individual doses were calculated based on the initial body weights, taking into account the
density (detennined by PSL) of the test substance.
Dosing:
The test substance was administered to the stomach using a stainless steel ball-tipped gavage
needle attached to an appropriate syringe. Following administration, each animal was returned to
its designated cage. Feed was replaced approximately 3-4 hours after dosing.
Cage-Side Observations
The animals were observed for mortality, signs of gross toxicity, and behavioral changes
approximately 30 minutes post-dosing, during the first several hours post-dosing and at least once
daily thereafter for 14 days after dosing. Observations included gross evaluation of skin and fur,
eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems,
somatomotor activity and behavior pattern. Particular attention was directed to observation of
tremors, convulsions, salivation, diarrhea, and coma.
Body Weights
Individual body weights of the animals were recorded prior to test substance administration
(initial) and again on Days 7 and 14 (terminal) following dosing.
Necropsy
All rats were euthanized via CO, inhalation at the end of the 14-day observation period. Gross
necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal
cavities were examined. - Statistics:
- Statistical analysis was limited to the calculation of the mean density value for dosing.
- Preliminary study:
- An initial limit dose of 2000 mg/kg bw was administered to one healthy female rat by oral gavage
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no effects observed
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- No gross abnormalities. see attached table.
- Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of E17 -194T is greater than 2000 mg/kg/ body weight in female rats.
E17-194T is not subject to GHS classification - Executive summary:
An acute oral toxicity test was conducted with rats to determine the potential for E17-194T to
produce toxicity from a single dose via the oral route. Under the conditions of this study, the
acute oral LDso of the test substance is greater than 2000 mg/kg of body weight in female rats.
An initial limit dose of 2000 mg/kg was administered to one healthy female rat by oral gavage.
Due to the absence of mortality in this animal, four additional females received the same dose
level, sequentially. Since these animals survived, no additional animals were tested. Females
were selected for the test because they are frequently more sensitive to the toxicity of test
compounds than males. All animals were observed for mortality, signs of gross toxicity, and
behavioral changes at least once daily for 14 days after dosing. Body weights were recorded
prior to administration (initial) and again on Days 7 and 14 (terminal) following dosing.
Necropsies were performed on all animals at terminal sacrifice.
All animals survived test substance administration, gained body weight, and appeared active and
healthy during the study. There were no signs of gross toxicity, adverse clinical effects, or
abnormal behavior. No gross abnormalities were noted for any of the animals when necropsied at
the conclusion of the 14-day observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch score 1: guidelines study and according to GLP
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 26, 2017 - January 10, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nousan-8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Housing: The animals were singly housed in suspended stainless steel caging, which
conforms to the size recommendations in the most recent Guide for the Care and Use
of Laboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g., toy) was placed
in each cage. Litter paper was placed beneath the cage and was changed at least
three times per week.
Animal Room Temperature and Relative Humidity Ranges: 20-23°C and 31-56%,
respectively.
Animal Room Air ChangeslHour: 12. Airflow measurements are evaluated regularly
and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 19 or 20 days
Food: Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was
available ad libitum.
Water: Filtered tap water was supplied ad libitum. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Two thousand milligrams of the test substance per kilogram of body weight was applied evenly
over a dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface)
and covered with a 2-inch x 3-inch, 4-ply gauze pad. The gauze pad and entire trunk of each
animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to
minimize loss of the test substance. The rats were then returned to their designated cages. The day
of application was considered Day 0 ofthe study.
After 24 hours of exposure to the test substance, the pads were removed and the test sites were
gently cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove
any residual test substance. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg /kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- Two thousand milligrams of the test substance per kilogram of body weight was applied to the
skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross
toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded
prior to application (initial) and again on Days 7 and 14 (terminal). Necropsies were performed
on all animals at terminal sacrifice. - Statistics:
- Statistical analysis was limited to the calculation of the mean density value for dosing.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No
- Clinical signs:
- other: All animals survived test substance administration and gained body weight during the study. Apart from one animal exhibiting erythema on Day I, there were no other adverse clinical findings recorded for any animals over the course of the study. No gross a
- Gross pathology:
- No gross abnormalities were
noted for any of the animals when necropsied at the conclusion of the l4-day observation period See attached table 3 - Other findings:
- None
- Interpretation of results:
- other: Not subject to classification under GHS
- Conclusions:
- Under the conditions of this study, the single dose acute dermal LD50 ofE17-194T is greater than
2000 mg/kg of body weight in male and female rats. - Executive summary:
SUMMARY
An acute dermal toxicity test was conducted with rats to determine the potential for
E17-194T to produce toxicity from a single topical application. Under the conditions of this
study, the single dose acute dermal LDso of the test substance is greater than 2000 mg/kg of body
weight in male and female rats.
Two thousand milligrams of the test substance per kilogram of body weight was applied to the
skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross
toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded
prior to application (initial) and again on Days 7 and 14 (terminal). Necropsies were performed
on all animals at terminal sacrifice.
All animals survived test substance administration and gained body weight during the study.
Apart from one animal exhibiting erythema on Day I, there were no other adverse clinical
findings recorded for any animals over the course of the study. No gross abnormalities were
noted for any of the animals when necropsied at the conclusion of the l4-day observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch score 1: guidelines study and according to GLP
Additional information
Justification for classification or non-classification
Not subject to GHS classification
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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