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EC number: 203-306-4 | CAS number: 105-54-4
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- data is from experimental reports following standard procedures.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- To determine the acute oral toxicity of test chemical in Sprague Dawley rats
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl butyrate
- EC Number:
- 203-306-4
- EC Name:
- Ethyl butyrate
- Cas Number:
- 105-54-4
- Molecular formula:
- C6H12O2
- IUPAC Name:
- ethyl butanoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Substance Type: Organic
- Physical State: Liquid
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0001
- Expiration date of the lot/batch:July; 2021
- Manufacturing Date: July; 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Test Item and prepared formulation(s) were stored at ambient temperature.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The dose of 300 mg/kg of test item was prepared by dilution of the test item in distilled water to obtain 30 mg/ml strength of solution. The formulation was prepared fresh on the day of dosing. The test item was administered in the dose volume of 10 ml/kg body weight. Actual preparation procedures are documented in the raw data. The dose of 2000 mg/kg of test item was administered undiluted as supplied by the Sponsor.
OTHER - Safety Precautions: Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses).
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females (if applicable) nulliparous and non-pregnant: [yes/no] : yes
- Age at study initiation: Healthy young adult females were used. The age at study initiation was 8 to 12 weeks old
- Weight at study initiation: Body weights at the start : Female Mean : 199.48 g (= 100 %); Minimum : 194.3 g (- 2.60 %); Maximum : 207.2 g (+ 3.87 %)
- Fasting period before study: fasted rats (approximately 16 hours or more)
- Housing:polycarbonate cages.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum):Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period:All animals were acclimatized to laboratory conditions for minimum of 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 to 22.0 degree centigrade
- Humidity (%): 53.1% to 58.2%.
- Air changes (per hr): ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: From: 31-05-2017 To: 19-06-2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg/kg and 2000 mg/kg
- Amount of vehicle (if gavage):10 ml per kg of body weight
MAXIMUM DOSE VOLUME APPLIED: 10 ml per kg of body weight was considered the maximum volume which could be administered to a rat.
DOSAGE PREPARATION (if unusual): The dose of 300 mg/kg of test item was prepared by dilution of the test item in distilled water to obtain 30 mg/ml strength of solution.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:The doses were selected based on the available literature of the test item. - Doses:
- Dose Group I : 300 mg/kg
Dose Group II : 2000 mg/kg - No. of animals per sex per dose:
- Three females were used at each step
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical Observations and General Appearance: Animals were observed for clinical signs, mortality and morbidity, until sacrifice.Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at immediately (0 to 5 minutes), 5, 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time. The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Body weights: Individual animal body weights were recorded, before fasting, prior to administration of the test item (fasting body weights), weekly thereafter and at termination on day 14. Weight changes were calculated and recorded.
Gross Pathology: Necropsy was performed on all animals at the end of the study period on day 15. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique.
Histopathology: No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Statistics:
- Mean ± SD
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No mortality was observed at all the tested concentrations at all times
- Clinical signs:
- other: No clinical signs and signs of toxicity were observed.
- Gross pathology:
- Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.
- Other findings:
- - Histopathology: No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.
Any other information on results incl. tables
Table 1: Summary of Clinical Signs of Toxicity and Mortality
Sprague Dawley Rat
Sex : Female
Group I :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
300 |
No clinical signs observed |
3 |
1,2,3 |
Day 0 - Day 14 |
0/3 |
Group I :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
II |
300 |
No clinical signs observed |
3 |
4,5,6 |
Day 0 - Day 14 |
0/3 |
Group II :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
3 |
7,8,9 |
Day 0 - Day 14 |
0/3 |
Group II :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
II |
2000 |
No clinical signs observed |
3 |
10,11, 12 |
Day 0 - Day 14 |
0/3 |
Table 2: Mean Body Weight and Percent Body Weight Gain (g)
Sprague Dawley Rat
Sex : Female
Group I :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
300 |
Mean |
199.03 |
205.60 |
3.32 |
223.10 |
8.51 |
12.11 |
± SD |
3.23 |
1.90 |
2.28 |
2.48 |
0.63 |
2.11 |
Group I :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
II |
300 |
Mean |
203.43 |
209.37 |
2.91 |
227.20 |
8.52 |
11.68 |
± SD |
4.60 |
5.75 |
0.75 |
5.64 |
0.37 |
0.43 |
Group II :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
2000 |
Mean |
199.17 |
206.67 |
3.77 |
227.90 |
10.27 |
14.43 |
± SD |
2.14 |
2.81 |
1.00 |
4.19 |
0.67 |
1.78 |
Group II :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
II |
2000 |
Mean |
196.30 |
201.80 |
2.80 |
220.83 |
9.44 |
12.50 |
± SD |
2.17 |
2.61 |
0.20 |
1.40 |
1.13 |
0.94 |
Table 3: Summary of Gross Pathological Findings
Sprague Dawley Rat
Sex : Female
Group I :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
300 |
1 - 3 |
TS |
No abnormality detected |
Group I :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
II |
300 |
4 - 6 |
TS |
No abnormality detected |
Group II :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
7 - 9 |
TS |
No abnormality detected |
Group II :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
II |
2000 |
10 - 12 |
TS |
No abnormality detected |
TS = Terminal Sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral LD50 value for test chemical can be considered to be >2000mg/kg. Hence, it was concluded that the acute toxicity of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP.
- Executive summary:
The study was designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats. The study was performed according to OECD 423 - Acute Toxic Class Method. Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Group I Step I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Group I Step II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Group II Step I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Group II Step II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality or gross pathological abnormalities were observed in animals from 300 mg/kg and 2000 mg/kg dose groups. Therefore, the acute oral LD50 value for test chemical can be considered to be >2000mg/kg. Hence, it was concluded that the acute toxicity of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP.
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