Bureau of Indian Standards (BIS) is the National Standard Body of India. BIS is responsible for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS through its core activities of standardization and conformity assessment, has been benefiting the national economy by providing safe, reliable and quality goods; minimizing health hazards to consumers; protecting the environment, promoting exports and imports substitute; controlling over proliferation of varieties etc. Dermatological testing assesses a product's potential to cause skin irritation or allergic reactions. A product is considered dermatologically tested if a qualified dermatologist supervises the testing and verifies the results. Some dermatological tests include: Repeat-insult patch testing: Stability testing: Cosmetics toxicology test: 

1. Dermatological testing as per
BIS
Asst Professor : Jagruti N. Marathe

2. Bureau of Indian
Standards
Bureau of Indian Standards (BIS) is the National
Standard Body of India.
BIS is responsible for the harmonious
development of the activities of standardization,
marking and quality certification of goods and for
matters connected therewith or incidental thereto.
Presentation title 2

3. Bureau of Indian
Standards
BIS through its core activities of standardization
and conformity assessment, has been benefiting
the national economy by providing safe, reliable
and quality goods; minimizing health hazards to
consumers; protecting the environment, promoting
exports and imports substitute; controlling over
proliferation of varieties etc.
Presentation title 3

4. Bureau of Indian
Standards
The standards and certification scheme of BIS
apart from benefitting the consumers and industry
also support various public policies especially in
areas of product safety, consumer protection, food
safety, environment protection, building and
construction, etc.
Presentation title 4

5. OBJECTIVES OF BIS
Harmonious development of the activities of
standardization, marking and quality
certification of goods.
To provide thrust to standardization and
quality control for growth and development of
industry on one hand and to meet the needs
of consumers on the other.

6. BIS
• Emphasis on patch
testing,
• repeated insult patch
testing cumulative
irritation test
• Photo allergic test
• Photo toxicity test.
6

7. BIS
Emphasis on patch testing
Photo allergic
Repeated insult patch testing Cumulative
Photo toxicity
Presentation title 7

8. Dermatological testing assesses a product's
potential to cause skin irritation or allergic
reactions.
A product is considered dermatologically
tested if a qualified dermatologist
supervises the testing and verifies the
results.
8

9. Some dermatological tests include:
Repeat-insult patch testing:
Stability testing:
Cosmetics toxicology test:
9

10. Repeat-insult patch testing: A process
that involves applying small amounts of
substances to human volunteers to test
for allergic reactions.
Stability testing: Determines if cosmetic
goods will keep their function, physical,
chemical, and microbiological features
during their shelf life and use
Cosmetics toxicology test: Determines
if any of the product's ingredients can
cause harm
10

11. Patch test
Presentation title 11
•Patch testing is generally done to see whether a particular substance is causing allergic skin
inflammation (contact dermatitis).
•Patch tests can detect delayed allergic reactions, which can take several days to develop.
•Patch tests don't use needles.
•Instead, allergens are applied to patches, which are then placed on your skin.
•During a patch test, your skin may be exposed to 20 to 30 extracts of substances that can cause
contact dermatitis.
•These can include latex, medications, fragrances, preservatives, hair dyes, metals and resins.
•The patches on your arm or back for 48 hours.

12. Patch test
Presentation title 12
•During this time, individual should avoid bathing and activities that cause heavy sweating.
•The patches are removed when individual return to dermatologist .
•Irritated skin at the patch site may indicate an allergy.

13. Cumulative irritation test
Presentation title 13
•The Cumulative Irritation Test (CIT) is a longer trial to measure irritation response to a test
product – and changes in that response – over time.
•Patches of the product are applied to the skin and then are replaced daily (except weekend
days) through the course of the trial, usually five, 14, or 21 days. Evaluators observe, grade, and
record any signs of irritation daily during the trial period. A final reading is taken the last day of
patch removal.
•The goal of the CIT is to quantitate the irritation potential of the product.
•An additional “challenge” phase can be conducted after the CIT, usually two to three weeks after
completion.
•In this challenge phase, the product is introduced to a previously untested site to determine
whether sensitization has occurred.
•The goal of this phase is to evaluate the potential for sensitization.

14. Repeated insult patch testing
Presentation title 14
•The Repeated-Insult Patch Test (RIPT) is a two-phase process that is designed to evaluate the
sensitization potential of a product.
•Phase 1 is the induction phase, during which the subject’s skin is exposed to the product several
times, usually nine to ten times.
•After completion of Phase 1, subjects are given a two-week “rest period.” In any subject who will
become sensitized to the product, the immune system will use this time to create the specialized
proteins in the body that would bring about an allergic reaction upon subsequent exposures.
•In Phase 2, the elicitation phase, the product is reapplied to a new site on the subject’s skin to
determine whether the repeat application will elicit an allergic reaction, showing that sensitization has
occurred.

15. Photoallergic patch testing
Presentation title 15
•A photo patch test can detect photo allergic reactions to various antigens, such as:
•Sunscreens, Drugs, Fragrances, Rubbers, Metals
A photo patch test can also determine if a skin rash is caused by:
An allergy to certain chemicals
An allergy to UV light
A chemical that is activated by sunlight
Other tests for photo allergy include:
Ultraviolet (UV) light testing: Also called photo testing, this exam measures how your skin reacts to light
from a special lamp.
Photo maximization test: This procedure identifies topical photo contact sensitizers.

16. Photo toxic testing
Presentation title 16
•A phototoxic reaction, also known as photo irritation, is an acute light-induced, non-immunological skin
response that occurs when a substance is applied to the body and subsequently elicits a toxic skin
reaction after exposure to UV light.
•For a chemical to demonstrate photo toxicity, it must:
(1) absorb light within the range of natural sunlight (290–700 nm),
(2) generate reactive species following absorption of UV-visible light, and
(3) be applied to or distribute to light-exposed tissues (e.g., skin).

17. Photo toxic testing
Presentation title 17
• Symptoms from phototoxic reactions include
•burning sensations,
•redness,
•rashes,
•lesions,
•and blistering

18. THANK YOU
Presentation title 18