Ethyl 2-methylbut-3-enoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-08-04 to 2009-08-25; day of dosing: 2009-08-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001-12-27

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008-05-30

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 423

Deviations:

no

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 (2R)-2-methylbut-3-enoate; ethyl (2S)-2-methylbut-3-enoate

EC Number:

700-224-5

Cas Number:

1647-12-7

Molecular formula:

C7 H12 O2

IUPAC Name:

ethyl (2R)-2-methylbut-3-enoate; ethyl (2S)-2-methylbut-3-enoate

Details on test material:

- Name of test material (as cited in study report): 2-Methylbuten-3-säureethylester
- Physical state: Liquid/ colorless, clear
- Analytical purity: 99.2 wt%
- Lot/batch No.: 34649/199/Fr.3
- Stability under test conditions: the stability under storage conditions over the study period was guaranteed by BASF SE
- Storage condition of test material: at room temperature
- Other: density: 0.885 (determined by Bioassay
No further data.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
female Wistar/Crl:WI (Han) rats
Rats were selected since this rodent species is recommended in the respective test guidelines. Wistar rats were selected since there is extensive experience available in the laboratory with this strain of rats. As suggested by the OECD guideline nulliparous and non-pregnant female animals were used for the test, because there is no indication that male animals are likely to be more sensitive to the acute effects of the test substance.
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: individual body weights were in the range between 174 and 183 g.
- Fasting period before study: yes; feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cage, type III
- Diet (ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 20 - 80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2009-07-31 To: 2009-08-25

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.26 ml/kg of the unchanged, liquid test substance

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: By the request of BASF SE a starting dose of 2000 mg/kg body weight had been chosen in the first step with 3 female animals. As no animal died, 2000 mg/kg body weight was administered to 3 female rats in the second step. As no animal died in the second step the study was terminated.

Doses:

2000 mg/kg bw (2.26 ml/kg bw) of the unchanged, liquid test substance

No. of animals per sex per dose:

2 groups of 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- Individual body weights were determined shortly before administration (day 0), weekly thereafter and on the last day of observation.
-- Recording of signs and symptoms was made several times on the day of administration, at least once each workday for the individual animals.
-- A check for any dead or moribund animal was made at least once each workday.
- Necropsy of survivors performed: yes
- Other: No histological examinations were performed.

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No deaths and no clinical signs of toxicity were observed.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: The combined acute oral LD50 was calculated to be > 2000 mg/kg bw.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical findings were observed during clinical examination.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Any other information on results incl. tables

Table: individual and mean body weights

Group	1				2
Dose [mg/kg bw]	2000				2000
Animal no.	1	2	3	Mean weight ± SD	4	5	6	Mean weight ± SD
Body weight at study day [g]
0	183	180	180	181.0 ± 1.73	174	183	178	178.3 ± 4.51
7	201	195	196	197.3 ± 3.21	186	196	186	189.3 ± 5.77
14	207	204	202	204.3 ± 2.52	191	206	194	197.0 ± 7.94

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU, OECD GHS

Conclusions:

Under the conditions of this study the median lethal dose of 2-Methylbuten-3-säureethylester after oral administration was found to be greater than 2000 mg/kg body weight in rats.