3,5-dimethylhex-1-yn-3-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test done before GLP and Guidelines were established.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,5-dimethylhex-1-yn-3-ol

EC Number:

203-500-9

EC Name:

3,5-dimethylhex-1-yn-3-ol

Cas Number:

107-54-0

Molecular formula:

C8H14O

IUPAC Name:

3,5-dimethylhex-1-yn-3-ol

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The outbred Sprague-Dawley rat, weighing 202 to 283 grams, was used for this study. The animals were obtained from Buckshire Corp., Perkasie, PA 18944 (U.S.D.A. License #23-BL) and were nulliparous and non-pregnant.
The animals were housed and maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 86-23). The rats were acclimated to the laboratory for at least 5 days prior to dosing and the weight variation did not exceed +/- 20% of the mean weight for each sex.
The animals were individually identified by an ear punch. Each cage was identified with a cage card, displaying the project number, animal
number, sex, date dosed, dose level and responsible technician's initials.

Temperature: 18°C - 26°C (64.4°F - 78.8°F)

Relative Humidity, %: 40 - 70

Light: 12-hour lightldark cycle

Diet: Wayne Rodent-Blox and tap water were provided gd libitum. Based on our current knowledge, no contaminants are known to be in this diet or water which might be expected to interfere with the objectives of the study.

Caging: Stainless steel elevated wire mesh flooring, 5 ratslcage by sex.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was administered as supplied, at a dose level of 200 mg/kg.
One group of ten (5 male & 5 female) albino rats was deprived of food but not water overnight prior to dosing. Each animal was weighed and dosed by direct administration of the test article into the stomach by gavage.
Following administration, the animals were allowed food and water ad libitum for the 14-day observation period during which time, the rats were observed for signs of toxicity and mortality. Animals were observed frequently on the day of dosing. A careful clinical examination was performed at least once each day (7 dayslweek). On weekdays, a second observation of mortalitylmoribundity was performed.
Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. The animals were euthanized using carbon dioxide at the conclusion of the observation period. Gross necropsies were performed on all animals.

Doses:

200 mg/kg

No. of animals per sex per dose:

5 mal and 5 female

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 500 mg/kg bw

Based on:

test mat.

Mortality:

none

Gross pathology:

Gross Pathology:

Males
No gross abnormalities were observed for the animals necropsied at the conclusion of the 14-day observation period.

Females
No gross abnormalities were observed for the animals necropsied at the conclusion of the 14-day observation period.

Other findings:

Observations:

Males

Immediate - 5/5 animals appeared normal.
1 hour - 5/5 animals appeared lethargic.
4 hours - 5/5 animals appeared normal.
Day 1 - 1/5 exhibited audible respiration (gasping);
4/5 animals appeared normal.
Day 2-Day 14 - 5/5 animals appeared normal.


Females

Immediate - 5/5 animals appeared normal.
1 hour - 5/5 animals appeared lethargic.
4 hours - 5/5 animals appeared normal.
Day 1 - 1/5 animals exhibited vocalization,
4/5 animals appeared normal.
Day 2-Day 14 - 5/5 animals appeared normal.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test article, when administered as supplied to 5 male and 5 female albino rats, appears to have an acute oral LD50 greater than 200 mg/kg.
Based on the results outlined in this study and considering the 1972 study, the LD0 is 200 mg/kg bw and it is believed that the LD50 is >300 mg/kg bw.

Executive summary:

The test article, when administered as supplied to 5 male and 5 female albino rats, appears to have an acute oral LD50 greater than 200 mg/kg.

Based on the results outlined in this study and considering the 1972 study, the LD0 is 200 mg/kg bw and it is believed that the LD50 is >300 mg/kg bw.