Registration Dossier
Registration Dossier
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EC number: 433-160-9 | CAS number: -
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30th July 2019 - 1st August 2019
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Human patch test performed to evaluate the skin irritation of chemicals in healty human volunteers (cosmetic research)
Data source
Reference
- Reference Type:
- other: own data
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Guideline:
- other: test with human volunteers
- Version / remarks:
- 24-hour occlusion human patch test
according to Japanese Standarts range ofpossible test results from "no visible reaction" to "large blister" T.Sugai, et.al., J.ofJapanese Cosmetic Science Society, Vol. 19, supp. 49-56 (1995)
- GLP compliance:
- not specified
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Specific details on test material used for the study:
- 50 % aq. solution
Method
- Type of population:
- general
- Subjects:
- 20 male and female test subjects 20 to 60 years old
subjects provided written informed consent after sufficient explanation of the study as the objective - Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- Finn Chambers on Scanpor tape
15 μl of test substance to each filter
test substance as 50 % aq. solution
physiological saline, purified water, white Vaseline as control - Examinations:
- substance was applied on the skin of subject's back and a test was performed for 24 hours.
At 2 hours and 24 hours after removal, the test site of the skin was pictured with a digital camera.
Results and discussion
- Clinical signs:
- none
- Results of examinations:
- The skin irritation index of the substance was for all test subjects "0.0" meaning no visible reaction.
Applicant's summary and conclusion
- Conclusions:
- The substance showed in a human 24 hours closed patch test no signs of skin irritation.
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