Registration Dossier

Diss Factsheets

Toxicological information

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:
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:
1997
Reference Type:
secondary source
Title:
No information
Author:
Symrise
Year:
2003
Bibliographic source:
HYDROLITE-5 SURVEY OF SAFETY STUDIES
Reference Type:
secondary source
Title:
No information
Author:
Symrise
Year:
2005
Bibliographic source:
MSDS - 616751 HYDROLITE-5

Materials and methods

Type of study / information:
48 h closed epicutaneous test
Endpoint addressed:
skin irritation / corrosion
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

Details on study design:
Hydrolite-5 was applied as 10% aqueous solution an the backs of 50 volunteers (30 females and 20 males). 14 of the volunteers had some history of allergy or were skin sensitive and were therefore considered to be specially sensitive. The test sites were assessed immediatly and 24 hours after patch removal.

Results and discussion

Results:
No irritant or doubtful reactions could be detected.

Applicant's summary and conclusion

Categories Display