Registration Dossier

Diss Factsheets

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:
2002
Reference Type:
secondary source
Title:
HYDROLITE-5 SURVEY OF SAFETY STUDIES
Author:
Symrise
Year:
2003
Reference Type:
secondary source
Title:
No information
Author:
Symrise
Year:
2005
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

Constituent 1
Chemical structure
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

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

Categories Display