Triglycerides, C16-C18 (even numbered) and C18 (unsaturated), maleated

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Autoradiographic study on percutaneous absorption of several oils useful for cosmetics

Author:

Suzuki, K. et al.

Year:

1978

Bibliographic source:

J. Soc. Cosmet. Chem.,29, 265-282 (May 1978)

Reference 2

Reference Type:

secondary source

Title:

Final Report on the Safety Assessment of Trilaurin, Triarachidin, ....

Author:

Cosmetic Ingredient Review Panel

Year:

2001

Bibliographic source:

International Journal of Toxicology, 20(Suppl. 4):61-94, 2001

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Percutaneous absorption of C14-label trioelein was evaluated in male hairless mice , which recievd topical application of radiactive oil onto the skin. Animals were scrificed on different time points and fate of substance was evaluated by whole body autoradiography with hairless mice a.

GLP compliance:

no

Remarks:

prior to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Glyceryl Trioleate

IUPAC Name:

Glyceryl Trioleate

Details on test material:

- Purity: labelled compounds were chemically and radiochemically pure as checked by thin layer chromatography using several different solvent systemsa nd scanningw ith a radiochromatograms cannerA loka TLC-2D.

Radiolabelling:

yes

Remarks:

14C

Test animals

Species:

mouse

Strain:

other: hr/hr

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean 25 g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

1, 6, 24 and 48 h

Doses:

- Nominal doses:
- Actual doses: 0.01 mL with activity adjusted to approximatelyto 0.2/µCi/mg

No. of animals per group:

no data

Control animals:

yes

Remarks:

other subszances

Details on study design:

TEST SITE
- Area of exposure: dorsal skin
- Preparation of test site: The hair on the dorsal region of animals was removed w ith a hair clipper and an electric shaver one day prior to topical application.
- Type of cover / wrap if used: 2.0 cm diameter Japanese papers backed w ith Lumirror© film covered with 3M Co.'s Micropore surgical tape

SAMPLE PREPARATION
- Preparation details: The mice were anesthetized with diethyl ether and immersed immediately in a dry ice acetone bath (-78 °C) at different intervals (1, 6, 24 and 48 h). Subsequently, whole body autoradiography was carried out according to the Ullberg method. Forty sagittal sections adhering to Scotch© Tape No. 810 (Sumitomo-3MC o., Ltd.) were prepared with a Jung type microtome from Yamatokoki Co., Ltd., in a freezing room (- l 5 °C). The sections were allowed to dry in that room, then brought into contact with Sakura X-ray film Industrial Type N (Konishiroku Photo Ind. Co., Ltd.), and exposed for 40 days. The film development was according to the usual procedure recommended by the manufacturer.

Results and discussion

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Remarks:

Slight erythema afetr 6 h, no effcets after 24 h

Any other information on results incl. tables

As determined by whole body autoradiography, 14C-Triolein did not penetrate into the body organs of mice. The oil remained localized at the application site at 48 hours post application.

Applicant's summary and conclusion

Conclusions:

No dermal absorption of 14C-labelled triolein was found after occlusive exposure for 48 in hairless mice.