Registration Dossier
Registration Dossier
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EC number: 305-673-7 | CAS number: 94944-95-3
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- photo toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 26 July 2005 to 29 July 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
- Type of study / information:
- photo toxicity in humans
- Endpoint addressed:
- other: photo toxicity
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Remarks:
- good Clinical Practice according to ICH Guideline E6
Test material
- Reference substance name:
- Fatty acids, C18-36, esters with ethylene glycol
- EC Number:
- 305-673-7
- EC Name:
- Fatty acids, C18-36, esters with ethylene glycol
- Cas Number:
- 94944-95-3
- Molecular formula:
- C40H78O4/C70H138O4
- IUPAC Name:
- Fatty acids, C18-36, esters with ethylene glycol
- Test material form:
- liquid - liquid: emulsion
- Details on test material:
- 40% solution in sesame oil
Lot 132-3206-2
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- 15 healthy human volunteers between 18 and 60 years of age of skin type II or IIi (II sensitive, III normal) with known mediacl history and filled out an Informed Consent Form were exposed at the lower back to the substance under occlusion during a 24 hour period, followed by irridiation with 0.5 MED of UVB and thereafter by 20 Joules of UVA. Three sites at the lowere back (free of sunburn, suntan, scars, dermal lesions and uneven skintones) were either not exposed and irridiated, exposed and irridiated and exposed and not irridiated. 24 and 48 hours after irridiation the minimal erythemal dose (MED) was determined. This dose is defined as the lowest time interval or dosage sufficient to induce defined erythema.
- Details on exposure:
- see above
source UV: Xenon Arc Simulator
Results and discussion
- Results:
- No phototoxic effects were observed in any of the subjects (see attached tables)
Any other information on results incl. tables
The demographic data on the subjects used in the test are included in the attached tables.
Applicant's summary and conclusion
- Conclusions:
- The substance when applied as 10% in sesame oil does not exhibit phototoxic effects.
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