Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.