Registration Dossier
Registration Dossier
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EC number: 433-160-9 | CAS number: -
Skin irritation / corrosion
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
