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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
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:
review article or handbook
Title:
Unnamed
Year:
1982

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: prospective clinical
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Prospective product safety testing with volunteers
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene distearate
EC Number:
211-014-3
EC Name:
Ethylene distearate
Cas Number:
627-83-8
Molecular formula:
C38H74O4
IUPAC Name:
ethane-1,2-diyl dioctadecanoate
Specific details on test material used for the study:
50% in mineral oil

Method

Type of population:
general
Ethical approval:
not specified
Remarks:
informed consent
Subjects:
125 subjects ages 19-76 years
Route of administration:
dermal
Details on study design:
Repeated dose patch test, with patches containing 0.25 g of sample for 24 h to dorsal upper arm. Patches were applied to the same site each Monday, Wednesday and Friday of a 3 week induction period. Each site was scored for irritation a total of nine times. After a 14 day rest period, challenge patches were applied to both arms of each subject; the sites were graded for sensitisation reactions after 48 and 96 hours.

Results and discussion

Results of examinations:
No visible signs of irritation were noted.
No visible signs of skin sensitisation were noted. All scores were zero.

Applicant's summary and conclusion

Conclusions:
In a clinical study of 125 subjects, a repeated insult patch test was undertaken with the test substance (50% in mineral oil). There was no evidence of irritation or sensitisation.