Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Health surveillance data

Currently viewing:

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Study type:
other: study with volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
Repetitive epidermal contact of the test substance to induce primary or cummulative irritation and/or allergic contact sensitization was studied.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Propane-1,3-diol
EC Number:
207-997-3
EC Name:
Propane-1,3-diol
Cas Number:
504-63-2
Molecular formula:
C3H8O2
IUPAC Name:
propane-1,3-diol
Details on test material:
- Purity: 99.95%

Results and discussion

Results:
The test substance did not indicate a clinically significant potential for dermal irritation.

Any other information on results incl. tables

The vehicle controls were negative for skin reactions throughout the test interval.

 

25% at pH 7: Two subjects exhibited a barely perceptible response 24 hours post-challenge application. These sites were negative at the final observation. The transitory responses were considered clinically insignificant.

 

50% at pH 7: Three subjects exhibited a barely perceptible or mild response 24 hours post-challenge application. These sites were negative at the final observation. A different subject exhibited a mild to barely perceptible response 24 and 72 hours post challenge. No other dermal sequelae was observed. These weak, transitory responses were considered clinically insignificant.

75% at pH7: Six subjects exhibited a barely perceptible response 24 and possibly 72 hours post challenge. However, most of these sites were negative at final observation. No other dermal sequelae was observed. These weak, transitory responses were considered clinically insignificant.

 

75% at pH 4: Six subjects exhibited a mild and or barely perceptible response post-challenge application. No other dermal sequelae was observed. These weak, transitory responses were considered clinically insignificant.

 

75% at pH 9: Six subjects exhibited a mild and or barely perceptible response post-challenge application. No other dermal sequelae was observed. These weak, transitory responses were considered clinically insignificant.

Applicant's summary and conclusion

Conclusions:
The test substance did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.
Executive summary:

1,3-Propanediol was tested at various concentrations and pHs to determine its potential to cause irritation or delayed contact hypersensitivity in humans. Under the conditions of the study, the test substance did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.