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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Sensitisation data (human)

Currently viewing:

Administrative data

sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Occupational health statement

Data source

Reference Type:
other: Occupational health statement
Report date:

Materials and methods

Type of sensitisation studied:
Study type:
other: occupational health statement
Principles of method if other than guideline:
Expert statement from occupational health physicians on the basis of in-house human experience.
GLP compliance:

Test material

Constituent 1
Reference substance name:
Vinasses, residue of fermentation
EC Number:
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
Vinasses, residue of fermentation
Details on test material:
- Name of test material (as cited in study report): Vinasses
- Analytical purity: no data


Type of population:
Ethical approval:
not applicable
not applicable
Route of administration:

Results and discussion

Results of examinations:
After years of working in the production of Vinasses, none of the employees has shown any allergic skin reaction that would have been caused by contact with this product.

Any other information on results incl. tables

Cited from the statement (original text in French):

"We, the undersigned, Dr. Nathalie BROUCK and Prof. Paul FRIMAT, occupational health physicians of the Société Industrielle Lesaffre (SIL), responsible for occupational health surveillance of the company's employees, hereby certify that vinasses have been produced for several years in this company. So far, none of these employees in the production of vinasses showed any allergic skin reaction that would have been caused by contact with this product. Therefore, if the vinasses had a skin sensitising potential, one might reasonably expect that cases of skin allergy had been developed, since most of the employees have been working in the production of vinasses for many years."

Applicant's summary and conclusion