Our Services

Primary irritation patch test (PIPT)

  • This test is indicated for assessment of the irritancy potential of a test product.
  • We conduct a study with 24 hours application of patch test for irritancy assessment. The parameters such as glaze, wrinkles, scaling and edema are assessed as per the Draize scale scoring system. 
  • This Test is performed as per BIS 4011: 2018 and the international regulatory and International Contact Dermatitis Research Group's (ICDRG) methodology

Contact hypersensitivity Testing

  • This test is indicated for detection of allergy and sensitization potential of test product
  • It is conducted by 24 hours application of a patch test and the results are assessed after 48 hours, 3 and 5 days, respectively.
  • The results are assessed with parameters of redness and papules as per ICDRG.
  • It is conducted as per BIS 4011: 2018 and the international regulatory guidelines.
  • This test is a qualitative determinant of T- cell mediated system immunology.

Photosensitivity diagnostic studies (Photo patch test)

  • Photosensitivity is an extreme sensitivity to ultraviolet (UV) rays from the sun and other light sources
  • This test is indicated for an estimation of photo irritation and photo allergy of the test product.
  • It is conducted by irradiation of 5-10 Joules/sq.cm UVA on a test area 
  • It will be assessed for irritancy after 24 hours and allergic potential after 48 hours, 72 hours and 5 days, respectively

Human Repeat Insult Patch Test (HRIPT)

The human repeated insult patch test (HRIPT) methodology is commonly used to investigate the risk potential for a possible irritant and/or sensitizing agent that triggers a reaction when in contact with human skin under exacerbated conditions of product exposure.

  • HRIPT protocols are of particular benefit to validate a no-effect level of sensitization to a product or its components in comparison with a control substance.
  • The application of test products under occlusion favors a high level of skin contact thus maximizing the detection of any irritant or allergenic potential of the product
  • Hypoallergenic
  • Dermatologically tested product
  • Clinically tested product
  • Suitable for sensitive skin

    • HRIPT is beneficial for the claims of products such as
    • With induction phase, rest phase and challenge phase, the study is carried in 200 volunteers for 3 months
    • It is conducted as per BIS and /or International regulatory guidelines.

    Human Repeat Insult Photo Patch Test

    • It is indicated to find photo allergenicity testing after conducting HRIPT
    • The test area is exposed to UVA irradiation in induction and challenge phase similar like in HRIPT
    • The results are scored as per ICDRG scales

     Use Test

    • It is conducted after the cosmetic testing product has passed the appropriate tests
    • It is performed for safety evaluation of the testing product
    • It is conducted on 15 volunteers for 15 days

    Exposer and Withdrawal Test 

    •  It is useful for suspected test product and /or in multiple use of suspected allergic test products

    Restricted Consumer Test

    • It is a post marketing surveillance study of the cosmetic and personal care products on a limited scale  
    • The aim and objective of the study is to assess the safety and stability with respect to the safeguarding of consumers along with efficacy 
    • It is commonly done between 5000 and 10000 units of cosmetics as per BIS directives

    • These are study of safety and efficacy evaluation with appropriate, suitable and advanced study methodologies
    • It is essential for regulatory guidelines.
    • It is conducted as per the GCP guidelines and advanced instrumentation to conclude with robust evidences.
    • We perform claim studies of the all products listed in Schedule 'S' (Click Here to go to list of Cosmetic products) of the Drugs and Cosmetic Act, also of personal care products and nutraceuticals.
    •  It is performed for safety and efficacy of new drug and medical devices as per GCP and Schedule "Y" guidelines.
    • It is a study of the side-effects of cosmetics. 
    • It is useful to analyse and estimate long-term and cumulative side-effects of the testing products.
    • It is useful for industries, academia, and regulatory authorities.

    Sanity Lifesciences Pvt. Ltd

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