Safety of cosmetic materials 379 TEST CONDITIONS The experimental conditions were rigorously standardized: A physico-chemical analysis was carried out on each sample followed by gas chromatography and a determination of peroxide index to show any chemical deterioration or the presence of impurities. The safety evaluation was conducted using the following tests: Determination of the ocular irritation index (O.I.I.) Determination of primary cutaneous irritation index after one occlusive application (P.I.I.) Determination of cumulative cutaneous irritation index after repeated exposures The test procedure is described in the 'Journal Officiel de la R•publique Fran• aise' of 21.4.71 and 5.6.73 (15) but the following additions or modifications have been made Ocular irritation test: Reading after 1 h, in addition to those of 24 h, 2d, 3d, 4d and 7d Photomotor reflex study Use of strips of sterile paper impregnated with fluorescein to help to demonstrate the presence of corneal opacification and to evaluate the extent of surface attack A qualitative evaluation of any ulceration or granulation Use of an ophthalmoscope and a retinograph Interpretation of the results using an evaluation scale from 0 to 100. Primary cutaneous irritation test: Use of occlusive patches 'Neodermotest' Fixing of the patches using absorbent gauze held in place by adhesive tape Housing in individual cages (600 x 540 x 315 mm) Modification of the evaluation scoring: non irritant, less than 0.5, slightly irritant 0-5 to 2 (cf. Journal Officiel non irritant-----0 and slightly irritant from 0 to 2). Cumulative cutaneous irritation test: Reduction of the length of treatment: from 3 months to 8 weeks Wiping off the excess of substance with gauze Daily readings expressed as a weekly average Qualitative evaluation of thickening and drying of the skin After 8 weeks of treatment systematic histological examination of two samples of skin A study of recovery from cutaneous injuries, by stopping application for 7 days and examining the skin after this rest Challenge assay to determine whether the reactions observed have irritant or allergic origin. RESULTS Chemical study In checking through specifications and analytical records, one must consider that the materials correspond to those regularly used in the industry. A qualitative selection was purposely not made as it was desirable to study those readily available on the market.
380 J. P. Guillot, M. C. Martini and d. Y. Giauffret . , , Figure 1. Comparative gas-liquid chromatograms of the triglycerides. Temperature programme: 240ø-300øC. at 5øC./min on 2'5% SE 30, 80/100 mesh chromosorb W AW DMCS. Solvent: acetone. Temp. Inj.: 320øC. Col.: 1 min at 240øC. --/3/ - --/4/ ......... /5/ ...... /6/. I Figure 2. Comparative gas-liquid chromatograms of the isopropyl myristates. Temperature: 170øC. on 10•o DEGS, 60/80 mesh chromosorb W HMDS. Temp. Inj.: 300øC. Col.: 2 mX¬ in. (glass). • =/7/ /8/ ...... =/9/ - /•o/.
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