Registration Dossier
Registration Dossier
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EC number: 293-215-6 | CAS number: 91052-54-9
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:
- weight of evidence
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
- skin sensitisation
- Principles of method if other than guideline:
- Patch test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, C16-18 mono-, di- and tri-
- EC Number:
- 293-215-6
- EC Name:
- Glycerides, C16-18 mono-, di- and tri-
- Cas Number:
- 91052-54-9
- Molecular formula:
- C19H38O4; C21H42O4; C35H68O5; C39H76O5; C51H98O6; C57H110O6
- IUPAC Name:
- Glycerides, C16-18 mono-, di- and tri-
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Lot/batch No.: 020903/1
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 50
- Sex: 15 males and 35 females
- Age: 28-69 (males) and 18-69 (females) years
- Diagnosis:
Healthy: 9 males and 22 females
Sensitive skin: 7 females
Atopic: 6 males and 6 females - Ethical approval:
- not specified
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- The test substance, diluted to 25% in paraffin oil, was applied once at 2 mg test substance/cm² to healthy skin on the back area of the test subjects using a commercial test patch. The patch was removed 48 h post-application.
- Examinations:
- - Skin reactions: skin reactions were evaluated immediately after patch removal (48 h post-application) and 24 h later (72 h post-application).
- Scoring system:
0: no irritation
±: slight or doubtful erythema
+: clearly recognisable erythema
++: strong erythema and/or papulation
+++: densly aggregated papules and/or vesicles
++++: blistering or necrosis
Results and discussion
- Clinical signs:
- No positive or doubtful skin reactions were observed at 48 and 72 h post-application in any subject. Thus, there was no indication that the test substance acts as a primary skin irritant. Furthermore, no skin reactions resulting from an existing sensitisation were induced in this test.
Applicant's summary and conclusion
- Conclusions:
- Not irritating. No evidence of an already existing sensitisation.
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