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EC number: 203-306-4 | CAS number: 105-54-4
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Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- To determine the acute dermal toxicity of test chemical in Sprague Dawley rats.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
- Details on test material:
- - Name of test material (as cited in study report): Ethyl butyrate
- Molecular formula : C6H12O2
- Molecular weight :116.16 g/mol
- Smiles notation : C(=O)(CCC)OCC
- InChl : 1S/C6H12O2/c1356(7)842/h35H2,12H3
- 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 test item was used undiluted and as supplied by the Sponsor.
OTHER - Safety Precautions: Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses).
Constituent 1
- Specific details on test material used for the study:
- 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 test item was used undiluted and 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:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Male and Female
- Source: National Institute of Biosciences, Pune.
- Age at study initiation: Young adult male and female rats aged between 8 – 12 weeks
- Weight at study initiation: Body weights at the start : Male - Mean: 258.62 g (= 100 %); Minimum : 251.4 g (- 2.79 %); Maximum : 266.4 g (+ 3.01 %)
Total No. of animals : 5
Female- Mean : 230.04 g (= 100 %); Minimum : 224.3 g (- 2.50 %); Maximum : 238.4 g (+ 3.63 %)
Total No. of animals : 5
- Housing:individually housed in polycarbonate cages with paddy husk as bedding
- 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 (%): 55.4% to 58.8%.
- 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: 06-06-2017 To: 21-06-2017
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal surface and sides from scapular to pelvic area
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: using a porous gauze dressing and non irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mgkg
- No. of animals per sex per dose:
- A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).
- 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, until sacrifice. Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 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.
Evaluation of Dermal Reaction: Dermal reaction was observed daily for study period of 14 days.
Body weights: Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology: Necropsy was performed on animals surviving at the end of the study. 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 (day 15).
Histopathology: No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no other details available
- Mortality:
- Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days - Clinical signs:
- other: Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days. Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in an
- Gross pathology:
- Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group
- Other findings:
- Evaluation of Dermal Reaction - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Any other information on results incl. tables
Table 1: Summary of Clinical Signs of Toxicity and Mortality
Sprague Dawley Rat
Sex : Male
Group 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 |
5 |
1 - 5 |
Day 0 - Day 14 |
0/5 |
Sex : Female
Group 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 |
5 |
6 - 10 |
Day 0 - Day 14 |
0/5 |
Table 2: Summary of Evaluation of Dermal Reaction
Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No dermal reaction observed |
5 |
1 - 5 |
Day 0 - Day 14 |
0/5 |
Sex : Female
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No dermal reaction observed |
5 |
6 - 10 |
Day 0 - Day 14 |
0/5 |
Table 3: Mean Body Weight and Percent Body Weight Gain (g)
Sprague Dawley Rat
Sex : Male
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
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 |
258.62 |
283.10 |
9.46 |
303.84 |
7.33 |
17.48 |
± SD |
5.70 |
6.54 |
0.57 |
7.88 |
1.51 |
1.35 |
Sex : Female
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
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 |
230.04 |
241.18 |
4.84 |
252.74 |
4.79 |
9.86 |
± SD |
5.50 |
6.35 |
0.50 |
7.32 |
0.44 |
0.83 |
Table 4: Summary of Gross Pathological Findings
Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
1 - 5 |
TS |
No abnormality detected |
Sex : Female
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
6 - 10 |
TS |
No abnormality detected |
TS = Terminal Sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal LD50 value for test chemical can be considered to be >2000mg/kg bw. Hence, it was concluded that the acute toxicity of test chemical, when applied via dermal 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 dermal toxicity profile of test chemical in Sprague Dawley rats. The study was performed according to OECD 402 Guidelines. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. No mortality or gross pathological abnormalities were observed in animals at the limit dose 2000 mg/kg bw. Therefore, the acute dermal LD50 value for test chemical can be considered to be >2000mg/kg bw. Hence, it was concluded that the acute toxicity of test chemical, when applied via dermal route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP.
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