Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
ndustrial Hygiene
The personal protective measure may be adapted appropriately when working in closed systems or under laboratory conditions.
Regular cleaning of equipment, work area and clothing.
Open handling at operator intervention points with local exhaust ventilation (e.g. downflow booths).
Internal working procedures available to personnel covering personal hygiene, standard cleaning, waste disposal and maintenance.
Personnel instructed and trained, regular refresher training established.
Double wardrobe must be available.
Open Handling
Respiration : Full face mask (EN136)
Filter : P3 (EN143)
Eye : Yes, by face mask
Hand : Normal length chemical-mechanical-resistant gloves (EN374/EN388)
worn over disposable gloves
Glove Material : Nitrile
Breakthrough time: 240 min
Thickness: 0.4 mm
Additional protection : Disposable dust-proof suit (EN465, type 4) worn over long underwear
Disposable boot covers, conductive

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion