Ethyl 2-methylbutyrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 May 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Any occasional deviations from the targets for temperature and humidity were considered not to have affected the purpose or integrity of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Any occasional deviations from the targets for temperature and humidity were considered not to have affected the purpose or integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-methylbutyrate

EC Number:

231-225-4

EC Name:

Ethyl 2-methylbutyrate

Cas Number:

7452-79-1

Molecular formula:

C7H14O2

IUPAC Name:

ethyl 2-methylbutanoate

Constituent 2

Reference substance name:

Ethyl Methylbutyrate-2

IUPAC Name:

Ethyl Methylbutyrate-2

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Ethyl Methylbutyrate-2
- Molecular formula (if other than submission substance): C7H14O2
- Molecular weight (if other than submission substance): 130.21 g/mol
- Physical state: Colourless liquid
- Analytical purity: 99.4
- Lot/batch No.:20010036
- Storage condition of test material: Approximately 4°C in the dark
- Other:
- Date received: 08 May 2000

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl: CD ® (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: males weighed 206 to 220g, and the females 206 to 217g
- Fasting period before study: An overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse SQC Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
- Water (e.g. ad libitum): With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse SQC Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
(Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study).
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: At the end of the observation period the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths (Individual mortality data are given in Table 1 of attached report).

Clinical signs:

other: There were no signs of systemic toxicity (Individual clinical observations are given in Tables 2 and 3 of attached report).

Gross pathology:

No abnormalities were noted at necropsy (Individual necropsy findings are given in Tables 6 and 7 of attached report).

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material, ETHYL METHYLBUTYRATE-2, in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

No mortalities were noted at 2000 mg/kg bodyweight.

No symbol and risk phrase are required according to EU labelling regulations.

Executive summary:

Study Sponsor: Haarmann & Reimer GMBH

Study Title: Acute Oral Toxicity Study in the Rat - Acute Toxic Class Method

Test Material: Ethyl Methylbutyrate-2

 

1. A study was performed to assess the acute oral toxicity of the test material following a single oral administration to the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 423 “Acute Oral Toxicity - Acute Toxic Class Method” (adopted 22 March 1996) and Method B1 tris of Commission Directive 96/54/EC (which constitutes Annex V of Council Directive 67/548/EEC).

 

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

 

2. Using all available information, 2000 mg/kg bodyweight was selected as the starting dose.

 

A group of three fasted females was treated with the starting dose. This was followed by a group of three fasted animals of the other sex at the same dose level. Dosing was performed sequentially.

 

The test material was administered orally, undiluted. The animals were observed ½, 1, 2 and 4 hours after dosing and then once daily for fourteen days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14. At the end of the observation period all animals were killed by cervical dislocation and subjected to gross necropsy.

 

3. There were no deaths.

 

4. There were no signs of systemic toxicity.

 

5. All animals showed expected gains in bodyweight over the study period.

 

6. No abnormalities were noted at necropsy.

 

7. The acute oral median lethal dose, (LD₅₀) of the test material, in the Sprague-Dawley CD strain rat, was estimated as being greater than 2000 mg/kg bodyweight. No mortalities were noted in animals treated with 2000 mg/kg bodyweight.

 

No symbol and risk phrase are required according to EU labelling regulations.