Oct-1-ene-3-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oct-1-ene-3-ol

EC Number:

222-226-0

EC Name:

Oct-1-ene-3-ol

Cas Number:

3391-86-4

Molecular formula:

C8H16O

IUPAC Name:

oct-1-en-3-ol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Bedoukian Research Inc.; 2005005-0019
- Expiration date of the lot/batch: December 22, 2006
- Purity test date: January 5, 2005

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: tightly sealed under inert gas in a cool, well-ventilated area
- Stability under test conditions: stable

Test animals

Species:

rat

Strain:

other: albino

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Indianapolis, Indiana, USA
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: at least 49 days old
- Weight at study initiation: 226.0-240.3 g
- Fasting period before study: night prior to dosing
- Housing: single animals in polycarbonate cages
- Diet (e.g. ad libitum): TEK 7012 Rodent Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 +/-5 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: April 25, 2005 To: May 17, 2005

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.09 mL

DOSAGE PREPARATION (if unusual): The test substance was dosed as is.

Doses:

The test used the up-and-down procedure. Dosages ranged from 99 mg/kg to 310 mg/kg.

No. of animals per sex per dose:

6 female animals were used. As the test used the up-and-down procedure, the number of animals at each dosage varied.
At 99 mg/kg only one animal was tested.
At 175 mg/kg 3 animals were tested.
At 310 mg/kg 2 animals were tested.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross lesions, histopathology

Statistics:

The program AOT425StatPgm was used for statistical analysis.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

175 mg/kg bw

Based on:

test mat.

95% CL:

>= 87 - <= 426

Mortality:

The only animal dosed at 99 mg/kg survived.
One animal from the 3 animal dosed at 175 mg/kg died. (1/3)
Both animals dosed at 310 mg/kg died. (2/2)

Clinical signs:

other: Animal 1 (175 mg/kg dose level) showed labored, slow breathing, catalepsy, and died during the first 4 hrs after dosing. Animal 2 (99 mg/kg dose level) and animal 5 (175 mg/kg level) showed piloerection. Animals 4 and 6 (310 mg/kg dose level) died within

Other findings:

- Histopathology: Animal 1 (175 mg/kg dose level) and animals 4 and 6 (310 mg/kg dose level) showed bright red livers and kidneys that were dark inside at the necropsy.

Any other information on results incl. tables

Animal	Weight Change (g)	Clinical Observations	Necropsy Observations
No. 1 at 175 mg/kg	N/A	Dyspnea, Catalepsy, Toxic Death	Bright red liver, kidneys dark inside
No. 2 at 99 mg/kg	22.9	Piloerection	Normal
No. 3 at 175 mg/kg	10.8	None	Normal
No. 4 at 310 mg/kg	N/A	Toxic Death	Bright red liver, kidneys dark inside
No. 5 at 175 mg/kg	9.1	Piloerection	Normal
No. 6 at 310 mg/kg	N/A	Toxic Death	Bright red liver, kidneys dark inside

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The acute oral LD50 is 175 mg/kg.

Executive summary:

The acute oral toxicity of 1-octen-3-ol was tested in an OECD Guideline 425 test using the up-and-down procedure. The first animal was dosed at 175 mg/kg. As that animal died, the second was dosed at 99 mg/kg. As the second animal survived, the third animal was dosed at 175 mg/kg. As the third animal survived, the fourth animal was dosed at 310 mg/kg. As the fourth animal died, the fifth animal was dosed at 175 mg/kg. As the fifth animal survived, the sixth animal was dosed at 310 mg/kg and then died. The LD50 was therefore determined to be 175 mg/kg with a 95% confidence limit of 87-426 mg/kg. This places the test substance in acute oral toxicity category 3 according to GHS guidelines.