Registration Dossier

Toxicological information

Sensitisation data (human)

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Administrative data

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

Data source

Reference
Reference Type:
other: Occupational health statement
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Type of sensitisation studied:
skin
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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinasses
- Analytical purity: no data

Method

Type of population:
occupational
Ethical approval:
not applicable
Controls:
not applicable
Route of administration:
dermal

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