(Z)‐ethyl 2‐methylpent‐3‐enoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11-10-1983 to 26-10-1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Z)‐ethyl 2‐methylpent‐3‐enoate

EC Number:

854-058-4

Cas Number:

58625-89-1

Molecular formula:

C8H14O2

IUPAC Name:

(Z)‐ethyl 2‐methylpent‐3‐enoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Labs, Wilmington, MA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Males: 8 to 9 weeks, Females 11 to 12 weeks
- Weight at study initiation: Males: 229 to 252g, Females: 218 to 244g
- Fasting period before study: the night prior to dosing
- Diet: Charles River R-M-H 3000, Lot #W2 3241, W2 3242

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Body weight: On first day of testing and on day 7 and 14.
- Clinical signs: Three times on the day of dosing and at least once daily thereafter. In addition, pharmacotoxic screening was performed on the day prior to dosing on all animals. Procedure was performed on 3 males approximately one hour after dosing on day 0, once on day 1, and once on day 2. This included the following measurements: pupil size, skin color, conjunctival membranes, grabbing performance, balance during standing and walking, attempt to escape, rectal temperature, and hearing.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

other: No signs of toxicity were observed.

Gross pathology:

No gross visible lesions detected.

Applicant's summary and conclusion

Interpretation of results:

other: not acute harmful according to EU CLP (EC 1272/2008 and its amendments)

Conclusions:

The substance has an LD50 of >5000 mg/kg bw in a similar to OECD TG 401 study.

Executive summary:

The acute oral toxicity has been studied in a similar to OECD TG 401 test. The substance was administered at a dose of 5000 mg/kg bw to 5 male and 5 female SD rats and animals were observed for 14 days. No mortality and no clinical signs were observed. There were no treatment related necropsy findings. There were no adverse effects on bodyweight gain in animals of either sex except for one female losing 5 grams of weight between day 7 and 14. The acute oral toxicity (LD50) was determined to be >5000 mg/kg.