(3E)-dec-3-en-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-04-16 to 2009-07-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3E)-dec-3-en-2-one

Cas Number:

18402-84-1

Molecular formula:

C10H18O

IUPAC Name:

(3E)-dec-3-en-2-one

Details on test material:

- CAS: 18402-84-1
- Purity: 98.57% to 99.11% w/w
- Batch No.: Lot KB 147-36-1
- Physical state: liquid
- Colour: Colorless to pale yellow
- Storage conditions: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

albino

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Received from Ace Animals, Inc., Boyertown, PA on April 7 and 21, 2009.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult (9-10 weeks)
- Weight at study initiation: 170-186 g
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Fasting period: Prior to each dosing, experimentally naive rats were fasted overnight by removing the feed from their cages.
- Acclimation period: 7-15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 34-69
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE : none

DOSAGE PREPARATION:
Individual doses were calculated based on the initial body weights, taking into account the specific gravity (determined by EPSL) of the test substance.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

4

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 mortality, signs of gross toxicity, and behavioral changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing or until death occurred.
Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma. Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing or after death.
- Necropsy of survivors performed: Surviving rats were euthanized via C02 inhalation at the end of the 14-day observation period. Gross necropsies were performed on all decedent and euthanized animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Statistics:

N.a.

Results and discussion

Preliminary study:

N.a.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One female died within two days of test substance administration. Prior to death, this animal was hypoactive and exhibited ano-genital staining, hunched posture, and soft feces.

Clinical signs:

other: One female died within two days of test substance administration. Prior to death this animal was hypoactive and exhibited ano-genital staining, hunched posture and soft faeces. The surviving animals exhibited ano-genital staining (3/3 animals) and/or were

Gross pathology:

Gross necropsy of the decedent revealed red intestines. No gross abnormalities were noted for the euthanized animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in rats conducted according to OECD 425, one female died within two days at a dose of 5000 mg/kg bw. Based on the results and in accordance with OECD guideline 425 the LD50 value was determined to be greater than 5000 mg/kg bw. Thus, the substance does not warrant classification as being toxic or harmful based upon its acute oral toxicity.

Executive summary:

An acute oral toxicity test was conducted in accordance with OECD test guideline 425 to determine the potential of (3E)-dec-3-en-2-one to induce acute oral toxicity in female Sprague-Dawley rats. An initial limit dose of 5000 mg/kg bw was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, two additional female animals received the same dose, one of which died. Therefore, a fourth animal was tested at this dose level and this animal survived. All animals were observed for mortality, signs of gross toxicity and behavioural changes at least once daily for 14 days.

Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing or after death. Necropsies were performed on all animals. One female died within two days of test substance administration. Prior to death this animal was hypoactive and exhibited ano-genital staining, hunched postures and soft faeces. The surviving females exhibited ano-genital staining, hunched posture, piloerection, reduced faecal volume, soft faeces and facial stains following test substance administration but recovered by Day 6 and appeared active and healthy, gaining bodyweight over the 14-day observation period. Gross necropsy of the decedent revealed red intestines; no gross abnormalities were noted for the euthanized animals when necropsied at the conclusion of the 14-day observation period. Based on the results the oral LD50 can be considered to greater than 5000 mg/kg bw.