Tetradecan-1-ol, propoxylated, esters with propionic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 14, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Acute Toxicity

Version / remarks:

Method by Hagen, E. C. (1959) in Appraisal of the Safety of Chemicals in Food, Drugs, and Cosmetics. Division of Pharmacology, Food and Drug Administration, Department of Health, Education, and Welfare, 17 - 25

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (2 mol PO)

Molecular formula:

C23H46O4

IUPAC Name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (2 mol PO)

Constituent 2

Reference substance name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (1 mol PO)

Molecular formula:

C23H46O4

IUPAC Name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (1 mol PO)

Constituent 3

Reference substance name:

Tetradecyl propionate

EC Number:

228-300-9

EC Name:

Tetradecyl propionate

Cas Number:

6221-95-0

Molecular formula:

C17H34O2

IUPAC Name:

tetradecyl propanoate

Constituent 4

Reference substance name:

PG-2 Tetradecan-1-ol

IUPAC Name:

PG-2 Tetradecan-1-ol

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Wistar-derived albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey (conditioned prior to use)
- Weight at study initiation: 186 - 242 g
- Fasting period before study: Fasted overnight prior to test material administration
- Diet: Ad libitum with Wayne animal feed
- Water: Ad libitum
- Acclimation period: Maintained under standard laboratory conditions for a minimum of seven days prior to test material administration

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Single dose of 5 g/kg bw

No. of animals per sex per dose:

Five male and five female rats were dosed individually

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post-dosage and thereafter on each day
- Necropsy of survivors performed: Complete gross necropsy performed at the conclusion of day 14

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Following an in vivo 14-day toxicity study in rats via the oral route, PPG-2 myristyl ether propionate was found not to have induced any symptoms of toxicity and was subsequently assigned an LD50 of >5 g/kg bw. Classification in line with CLP Regulation (EC) No. 1272/2008 is not required.

Executive summary:

An in vivo acute toxicity study via the oral route was undertaken in mixed sex Wistar-derived albino rats over a 14-day period according to the procedure recommended by Hagan (1959) in the Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. Following an overnight fasting period, a single dose of 5 g/kg PPG-2 myristyl ether propionate was administered by gavage according to bodyweight. Food and water were available ad libitum. All rats were observed for pharmacologic activity and toxicity at 1, 3, 6, and 24 hours post-dosage and thereafter on day 2, 3, 4, 5, 6, 7, and 14. Animals were then sacrificed and subjected to complete gross necropsy at the termination of the experiment. Over the study, no rats perished and no symptoms of toxicity were observed. Consequently, PPG-2 myristyl ether propionate was concluded not to be a toxic substance under the conditions of the test with an assigned LD50 of >5 g/kg bw. Hazard classification was not required (CLP Regulation (EC) No. 1272/2008).