Registration Dossier
Registration Dossier
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EC number: 294-601-7 | CAS number: 91744-39-7
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:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Human patch test
- GLP compliance:
- no
Test material
- Reference substance name:
- Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts
- EC Number:
- 294-601-7
- EC Name:
- Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts
- Cas Number:
- 91744-39-7
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts
- Details on test material:
- Test item was diluted 1 : 10 in water.
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- Human patch test with 40 volunteers
Duration of treatment: 24 h application of patches soaked with the test item
Observation: 24, 48 and 72 h after treatment - Exposure assessment:
- measured
Results and discussion
- Results:
- No irritation.
None of the 40 volunteers showed a skin reaction after treatment.
Applicant's summary and conclusion
- Conclusions:
- The test item (10%) is not irritating in humans.
- Executive summary:
To potential for irritation of the test item was determined in a patch test with humans. Test item was diluted 1:10 in water. 40 humans were exposed to the test item for 24 h by application of patches soaked with the test item. Observation were made after 24, 48 and 72 h after treatment.
No irritation could be observed. None of the 40 subjects showed a skin reaction after treatment.
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