Registration Dossier
Registration Dossier
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EC number: 232-452-1 | CAS number: 8031-44-5
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1977
- 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:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
- skin sensitisation
- Principles of method if other than guideline:
- The dermal tolerability of the substance was assessed in human volunteers.
- GLP compliance:
- no
Test material
- Reference substance name:
- Lanolin, hydrogenated
- EC Number:
- 232-452-1
- EC Name:
- Lanolin, hydrogenated
- Cas Number:
- 8031-44-5
- Molecular formula:
- UVCB: not available
- IUPAC Name:
- Lanolin, wool wax, hydrogenated
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- 14 subjects age 24-44 years participated (voluntarily) in this study. The substance was melted by using bain-marie.
The tested site was controlled after 24 and 48 hours by the same doctor and possible skin reactions such as erythema were noted (as present or absent). - Exposure assessment:
- not specified
- Details on exposure:
- For the application of the substance, a gauze of 4 cm2 was soaked with appr. 25 grams of the melted substance, and once cooled, it was applied on the palm. This gauze was then covered by another bigger gauze and it was fixed on the palm witn a patch tape.
Results and discussion
- Results:
- No evidence of dermal intolerance of the substance was noted. None of the subjects complained for itching or any other indications of intolerance.
Applicant's summary and conclusion
- Conclusions:
- The test material is tolerable by the human volunteers.
- Executive summary:
The substance was evaluated for its dermal tolerability on human volunteers. For this reason, 14 subjects age 24 -44 years were subjected to a dermal application of the test substance on the palm. The tested site was controlled after 24 and 48 hours by the same doctor and possible skin reactions such as erythema were noted (as present or absent).
No evidence of dermal intolerance of the substance was noted. None of the subjects complained for itching or any other indications of intolerance.
The test material is tolerable by the human volunteers.
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.
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