It is essential that a cosmetic product presents no risk to the consumer, and to ensure this, safety tests proposed by our experts are carried out before the product is placed on the market, enabling to assess its tolerance.

Several tolerance evaluation tests are proposed, such as compatibility tests, acceptability tests and immunotoxicity tests, detailed later.

But prior to clinical studies, IEC proposes in vitro methods for assessing the primary ocular tolerance of finished products [Hen’s Egg Test Chorion-Allantoic Membrane, J.O.R.F. of 26 December 1996], [Neutral Red Releasing Test, J.O.R.F. of 30 December 1999], [Bovine Corneal Opacity and Permeability, BCOP] and ingredients, [BCOP, OECD guideline n° 437], [MTT test on three-dimensional system, OECD guideline n° 492].

Primary cutaneous tolerance is assessed by the MTT conversion assay on Reconstructed Human Epidermis for both finished products and ingredients [OECD guideline n° 439].

The 3T3 NRU, OECD guideline n° 432 is used to determine the phototoxic potential of ingredients.

To assess skin compatibility on subjects, IEC proposes Skin Compatibility tests [48-hour single patch test,  “Elbow fold” Test, Repeated Open Application test on the forearm, Repeated patch test for one, 2, or even 3 weeks]. No claims are associated with these tests.

For the Ocular compatibility test, IEC can conduct Ocular projection test on rinsed, leave-on and solar products which claim “Does not sting or irritate the eyes / no tears (formulated in order its foam does not sting or irritate the eyes)” if coupled with a test of use under ophthalmological control (in the sun for a sunscreen product).

Acceptability tests correspond to In-Use tests performed under medical control: Dermatological control for the claims “tolerance tested under Dermatological control”, “suitable for sensitive skins”, “suitable for delicate skins”, “suitable for reactive skins”, “suitable for sensitive lips”, if at least 20 subjects with the corresponding criterion and no intolerance signal appearing on this subpopulation.

Acceptability tests can be performed with cosmetic products on  subjects presenting with skin conditions such as acne, atopic dermatitis, eczema or lucitein the subsidiary of IEC South Africa.

“Non comedogenic “can be claimed if at least 20 subjects from 18 to 40 years old, with oily or combination oily and prone to acne skin, with no statistically significant increase at the end of the study (in comparison with D0) in the number of retentional and inflammatory elements on face.

Under Ophthalmological control we claim ‘tolerance tested under Ophthalmological control’, and ‘suitable for sensitive eyes’, ‘suitable for lenses wearers’ if at least 15 subjects with the corresponding criterion and no intolerance signal appearing on this subpopulation.

Studies under Dental surgeon control are proposed in our Bulgaria and South Africa subsidiaries and enable to claim ‘tolerance tested under Odontological control’, ‘suitable for sensitive teeth’, ‘suitable for sensitive gums’, if at least 20 subjects with the corresponding criterion and no tolerance signal appearing on this subpopulation, ‘whitening effect’ (6-week test period required) by scoring and self-evaluation of teeth shade, ‘prevents the appearance/formation of plaque’ by scoring he dental plaque, ‘care for sensitive gums’ by evaluation of the effect on modified gingival index.

Gynecological control can be carried out in IEC Bulgaria in order to claim ‘tolerance tested under Gynecological control’, in at least 20 subjects.

Very specific studies can be carried out ‘under supervision of an allergist’ in South Africa.

Studies with a Pediatrician can be performed in IEC Bulgaria and IEC South Africa in order to support the claim ‘Tolerance tested under Pediatric control’, combined with a Dermatological control. To be able to test on these sensitive and fragile populations, preliminary safety data are mandatory such as in vitro ocular irritation test (Het Cam , BCOP or 3D skin models), 48 hour-Single patch test. As well as an In Use Test under Dermatological (and Ophthalmological also if required by the product) in adult subjects with at least 20 with a sensitive skin and 20-40% with history of atopy for 3 or 4 weeks) (or, if the product does not allow an in-use testing: Repeated Open Application test – ROAT) and Final clinical Safety Test (TCFS PSC) in at least 100 adult subjects to confirm the lack of cutaneous sensitization.

We also propose Immunotoxicity Tests on finished products in IEC Bulgaria : Sensitization Test (T.C.F.S.-P.S.C. according to ANSM recommendations of 2009), to determine skin primary and cumulative irritation, sensitization (type IV) potential, in at least 100 subjects.

-Photo-irritation (T.C.F.S.-P.T. according to ANSM recommendations of 2009) in 20 (or 25 if coupled to photo-sensitization test) subjects,

-Photo-sensitization Test (I.E.C. protocol or Sponsor’s specific protocol) in 25 subjects in standard.                                                                                                                                                                                 No claims are associated with these tests.

Our subsidiaries located in Asia (JAPAN, SINGAPORE, KOREA and CHINA) allow to test the products on Asian skins taking into account the specificities of each country in term of environmental conditions, culture, beauty routine and skin typology.

CONTACT

www.iecfrance.com

info@iecfrance.com