Registration Dossier
Registration Dossier
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EC number: 229-722-6 | CAS number: 6683-19-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1965
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP, number of participants only 50, test concentrations low. Limited amount of detail.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Patch tests were conducted on fifty human subjects according to the method of Shelanski and Shelanski (Procedures of the Toilet Goods Association, Number 19, 1953)
- GLP compliance:
- no
Test material
- Reference substance name:
- Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
- EC Number:
- 229-722-6
- EC Name:
- Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
- Cas Number:
- 6683-19-8
- Molecular formula:
- C73H108O12
- IUPAC Name:
- 3-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}-2,2-bis({[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}methyl)propyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Substance type: Organic
Constituent 1
Method
- Type of population:
- general
- Subjects:
- 50 volunteers
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: dimethyl phthalate
- Concentrations: 0.5% w/v
Results and discussion
- Results of examinations:
- None of the fifty subjects reacted to any of the 15 applications or to the challenge application.
Applicant's summary and conclusion
- Conclusions:
- From the results obtained in this study on the fifty subjects used, the test item tested as a 0.5% w/v solution in dimethyl phthalate, was found to be neither a primary; irritant nor a fatiguing agent to any of the subjects tested. This material did not produce sensitization in any of the subjects tested.
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