[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 - 23 May 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No information on purity was given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

no information on purity

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dimethylbutyl (E)-but-2-enoate

Molecular formula:

C10H18O2

IUPAC Name:

1,3-dimethylbutyl (E)-but-2-enoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 4 - 6 weeks
- Weight at study initiation: 120 - 152 g (males), 107 - 137 g (females)
- Fasting period before study: overnight prior to dosing until approx. 2 h after dosing
- Housing: 5 animals of the same sex per cage in polypropylene cages on sawdust
- Diet: Rat & Mouse Expanded Diet No. 1 (Special Diet Services Limited, Witham, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 ± 2.5
- Humidity (%): 45 - 60
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

A range-finding study was carried out to establish a dosing regimen for the main study.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

Range-finding study: 25, 200, 2000 and 5000 mg/kg bw
Main study: 5000 mg/kg bw

No. of animals per sex per dose:

Range-finding study: 2
Main study: 5

Control animals:

no

Details on study design:

Range-finding study:
- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed 0.5, 1 and 4 h after administration and subsequently once daily for 7 days.

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2, 3, 4 and 5 h after administration and subsequently once daily for 14 days. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period of the range-finding study and the main study.

Clinical signs:

other: Range-finding study: Abnormal body carriage (hunched posture) and pilo-erection were observed in all rats at all dose levels. Lethargy and ataxia were seen in rats at the 2000 mg/kg bw dose level and above while ptosis and a decreased respiratory rate wer

Gross pathology:

Post mortem examination of all rats killed at Day 14 revealed congestion of the lungs in two rats only. No macroscopic abnormalities were observed in any of the remaining animals.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.

Executive summary:

An acute oral toxicity study was performed with male and female rats according to OECD 401 under GLP conditions. After a range-finding study with the dose levels 25, 200, 2000 and 5000 mg/kg bw, a main study with 5000 mg/kg bw was performed. No mortality occurred during the study period of the range-finding study and the main study.

In this acute oral toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.