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Toxicological information

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:
2020
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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