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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
30th July 2019 til 1st August 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Cross-reference
Reason / purpose for cross-reference:
exposure-related information
Reference
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)
Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
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
Specific details on test material used for the study:
50 % aq. solution
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.
Clinical signs:
none
Results of examinations:
The skin irritation index of the substance was for all test subjects "0.0" meaning no visible reaction.
Conclusions:
The substance showed in a human 24 hours closed patch test no signs of skin irritation.

Data source

Materials and methods

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0 - 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
substance is non-irritant under the test concitions
(24h human patch test)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
substance is non-skin irritant

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