Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Sensitisation data (human)

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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 physician on the basis of in-house human experience.
GLP compliance:

Test material

Constituent 1
Reference substance name:
Vinasses, residue of fermentation, salt enriched
EC Number:
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
Vinasses, residue of fermentation, salt enriched
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 with Vinasses, none of the employees has reported any allergic reactions.

Any other information on results incl. tables

Cited from the statement:

"The undersigned, Dr. Roy Pieters, occupational physician of ArboUnie, responsible for health care at DSM Gist B.V. in, hereby certifies that:

-        Vinasses and Yeast extracts from Saccharomyces cerevisiae have been produced already for decades on this site

-        There is a close monitoring system in place for employees, considering health effects a.o. sensitization

-        None of the employees working with the above mentioned products have reported any allergic reactions

Since most employees have been working in this factory for many years, one could have expected that sensitization would have occurred in at least some cases, if yeast extracts and vinasses would have been potent sensitisers"

Applicant's summary and conclusion