Registration Dossier
Registration Dossier
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EC number: 255-392-8 | CAS number: 41484-35-9
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Human repeated insult patch test
- GLP compliance:
- no
Test material
- Reference substance name:
- Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- EC Number:
- 255-392-8
- EC Name:
- Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- Cas Number:
- 41484-35-9
- Molecular formula:
- C38H58O6S
- IUPAC Name:
- 2-[(2-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}ethyl)sulfanyl]ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Physical state: powder
- Analytical purity: no data provided
Constituent 1
Method
- Type of population:
- general
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: repeated insult patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive (3.0 cm x 3.0 cm)
- Concentrations: 10 mg/cm²
- Testing/scoring schedule: 15 applications and one challenge were done
- Removal of test substance: no data
EXAMINATIONS
- Grading/Scoring system:
0 = No reaction.
1+ = Slight erythema.
2+ = Marked erythema.
3+ = Marked erythema, edema, with or without a few vesicles.
4+ = Marked erythema, edema, with vesicles and oozing.
Results and discussion
- Results of examinations:
- SYMPTOMS
No visible skin changes signifying reaction to injury were observed in any of the subjects after any application.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions. 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
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