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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Remarks:
skin irritation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
clinical 48-hour patch test
GLP compliance:
no

Test material

Method

Ethical approval:
not specified
Remarks:
informed consent likely obtained
Details on study design:
48-hour closed patch test
Exposure assessment:
measured
Details on exposure:
20% test material in petrolatum was applied to 32 healthy male volunteers (ages not given) in a 48-hour closed patch test.

Results and discussion

Results:
Skin irritation was not observed

Applicant's summary and conclusion

Conclusions:
kin irritation was not observed when ethyl ricinoleate (20% in petrolatum) was applied in a 48-hour closed patch test in 32 healthy male volunteers.