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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

Constituent 1
Chemical structure
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
Chemical structure
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
Chemical structure
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
Body weight:
Body weight had increased in all rats by day 14 relative to day 0

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).

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