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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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