1,2,3-propanetriyl tris[12-(acetoxy)octadecanoate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Remarks:

This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

12 May 1981

Deviations:

yes

Remarks:

Only a single dose level was used in the study. This is considered not to effect the reliability of the test result.

GLP compliance:

no

Remarks:

The study was conducted in the USA in 1981, before the adoption of the OECD Principles of GLP in 1992.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3-propanetriyl tris[12-(acetoxy)octadecanoate]

EC Number:

205-363-0

EC Name:

1,2,3-propanetriyl tris[12-(acetoxy)octadecanoate]

Cas Number:

139-43-5

Molecular formula:

C63H116O12

IUPAC Name:

1,3-bis({[12-(acetyloxy)octadecanoyl]oxy})propan-2-yl 12-(acetyloxy)octadecanoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Albino, not otherwise specified.

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 222-270g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 male:5 female

Control animals:

not specified

Details on study design:

Ten (5M:5F) albino rats, 222-270 g, each received a single oral dose of the test article at a dose level of 5 grams per kilogram bodyweight. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6, and 21‘ hours after treatment, and daily thereafter for a total of 14 days. Non-survivors and animals surviving the ill day observation period were subjected to gross necropsy, with all findings noted. The test article was used as received (Sp.g. = 0.98).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the test period.

Clinical signs:

other: Not reported.

Gross pathology:

No effects were observed during gross necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 in the rat of the test material was determined to be >5000 mg/kg bw under the conditions of the test.

Executive summary:

In this guideline (OECD 401) study, conducted prior to the adoption of GLP, the test material (EC 205-363-0) was determined to have an acute oral LD50 to rats of >5000 mg/kg bw. The study was conducted via oral gavage at a single dose level (5000 mg/kg bw) in albino rats. No toxicological effects were reported.