Registration Dossier
Registration Dossier
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EC number: 604-195-9 | CAS number: 1406-66-2
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable study with limited information about test item.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Duhring-Kammer Test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tocopherols
- EC Number:
- 604-195-9
- Cas Number:
- 1406-66-2
- Molecular formula:
- not applicable
- IUPAC Name:
- Tocopherols
- Test material form:
- liquid: viscous
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 5
- Known diseases: healthy - Ethical approval:
- not specified
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- not specified
- Details on exposure:
- 70 µl of the test item was applied on the upper arm (Large Finn chamber) and left theier for 24 h under occlusive conditions.Erythema and edema scores were noted after 1, 24, 48, 72 and 144 h after removal of test item.
- Examinations:
- Erythema, edema
Results and discussion
- Clinical signs:
- Only one volunteer showed erythema and edema. The reactions were located in the area of the patch but not where the test item was applied.
Applicant's summary and conclusion
- Conclusions:
- The test item is well-tolerated by human skin. No signs of irritation were observed.
- Executive summary:
The toxic-irritative effect of the test item was investigated in the modified During-chamber test in five volunteers. No reactions were observed (erythema-edema). The test item is considered to be tolerated well on human skin.
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