1-cyclohexylethyl (E)-but-2-enoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Jul - 11 Aug 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Council Directive 84/449/EEC

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-cyclohexylethyl (E)-but-2-enoate

EC Number:

944-449-9

Molecular formula:

C12H20O2

IUPAC Name:

1-cyclohexylethyl (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. 5-8 weeks
- Weight at study initiation: 155-171 g (males), 150-161 g (females)
- Fasting period before study: overnight prior to administration until approx. 2 h after dosing
- Housing: up to 5 animals of the same sex per cage in solid-floor polypropylene cages on sawdust
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 48-66
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.12 mL/kg bw

A range-finding study was performed to derive the dose level of the main study.

Doses:

Preliminary study: 2000 mg/kg bw
Main study: 2000 mg/kg bw

No. of animals per sex per dose:

Preliminary study: 1
Main study: 5

Control animals:

no

Details on study design:

Range-finding study:
- Duration of observation period following administration: 5 days
- Frequency of observations: Animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 h after administration and subsequently once daily for 5 days.
- Necropsy of survivors performed: no

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

Results and discussion

Preliminary study:

No deaths were noted at 2000 mg/kg bw. Incidents of hunched posture were noted in the female 2 to 4 h after treatment. The dose level selected for the main study was therefore 2000 mg/kg bw.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period of the main study.

Clinical signs:

No signs indicative for systemic toxicity were noted during the main study.

Body weight:

In the main study, animals showed expected gains in bodyweight over the study period.

Gross pathology:

No abnormalities were noted at necropsy.

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 > 2000 mg/kg bw was derived in male and female rats.

Executive summary:

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 and in compliance with GLP (1993). Following a range-finding study, 5 male and 5 female rats were given a single oral dose of 2000 mg/kg bw. No mortality occurred and thus aLD50 value of >2000 mg/kg bw was derived.