Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976 – 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Objective of study:
other: corrosive/ irritation effects... (see attached file)
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Occupational Medical Assessment
GLP compliance:
no

Test material

Test animals

Species:
human
Sex:
male

Administration / exposure

Route of administration:
inhalation: dust
Vehicle:
unchanged (no vehicle)
Details on exposure:
dermal exposition
Duration and frequency of treatment / exposure:
n.a.
Doses / concentrations
Remarks:
Doses / Concentrations:
n.a.
No. of animals per sex per dose / concentration:
n.a.
Control animals:
no

Results and discussion

Applicant's summary and conclusion

Executive summary:

No indication of specific target-organic toxicity could be determined. This also applies for effects on the respiratory tract and the mucous membranes.