Registration Dossier
Registration Dossier
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EC number: 252-346-9 | CAS number: 35074-77-2
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: As this study was performed by a discredited CRO, the quality of this study is questionable and the reliability is unknown.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test with repeated Insult following the procedure of Draize, J. H. , Food Drug Cosmetic Law J., 10, 722 (1955) and Shelanski, H. A., and Shelanski, M. U., Proc Sci. Sect. Toilet Goods Assoc., 20, 46 (1953)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- EC Number:
- 252-346-9
- EC Name:
- Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- Cas Number:
- 35074-77-2
- Molecular formula:
- C40H62O6
- IUPAC Name:
- 6-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}hexyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Physical state: solid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 50
- Sex: male and female
- Age: 17 - 60 years old
- Race: caucasian and negro - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch:Readi-Band clear plastic patches, which are approximately 1 1/2 inch square and contain a 3/4 inch square nonwoven Webril center are utilized for all patch applications
- Vehicle / solvent: PEG-400
- Concentrations: 10 %
- Volume applied: 0.1 mL
- Testing/scoring schedule:
Induction phase: Application was done on three consecutive days. Patch was in contact with the skin for 23 hours. Grading for irritation approx. 30 to 60 minutes after Patch removal.
Challenge phase: One application, 12 days after the last induction application. Application and scoring pattern was similar to the induction phase. Additionally, delayed reactions were scored after 48 and 72 hours.
- Removal of test substance: no data
EXAMINATIONS
- Grading/Scoring system: Draize scoring
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No symptoms of any kind were observed throughout the study period in all participants except one. One male subject showed slight erythema after the sixth induction application. No other irritating effects were observed.
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 irritating reactions: 1
Applicant's summary and conclusion
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.
