Registration Dossier
Registration Dossier
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EC number: 226-285-3 | CAS number: 5343-92-0
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Reference Type:
- secondary source
- Title:
- HYDROLITE-5 SURVEY OF SAFETY STUDIES
- Author:
- Symrise
- Year:
- 2 003
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- Symrise
- Year:
- 2 005
- Bibliographic source:
- MSDS - 616751 HYDROLITE-5
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated Insult Patch Test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Pentane-1,2-diol
- EC Number:
- 226-285-3
- EC Name:
- Pentane-1,2-diol
- Cas Number:
- 5343-92-0
- Molecular formula:
- C5H12O2
- IUPAC Name:
- pentane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): Hydrolite-5
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 60 male and female volunteers. 53 subjects completed the study
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semiocclusive
- Vehicle / solvent: water
- Concentrations: 50%
- Volume applied: 0.2 ml
- Testing/scoring schedule: for induction 9 application for 24 hin 3 weeks; for challenge two weeks after last induction for 24 h
EXAMINATIONS
- Grading/Scoring: 24 h and 72 aftre patch removal
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/53
- Number of subjects with negative reactions: 53/53
None of the panelists reacted throughout the experiment. Hydrolite-5 was ver wy ell tolerated by the skin.
Applicant's summary and conclusion
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