Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: occupational medical statement
Adequacy of study:
supporting study
Study period:
1976 -2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non GLP-guideline study. Read-across from an occupational Medical Statement: Effects of BRUGGOLEN FF6 to exposed workers. Similarity of BLANCOLEN HP and BLANCOLEN HP BRUGGOLITE FF6 is a multi-constituent substance composed of • Disodium hydroxysulfinateacetate • Disodium hydroxysulfonateacetate • Sodium sulphite (as impurity) BLANCOLEN HP is the mono-constituent substance • Disodium hydroxysulfonateacetate During the manufacturing of BRUGGOLITE FF6 (the desired molecule is disodium hydroxysulfinate-acetate) the formation of disodium hydroxysulfonateacetate cannot be avoided. Sodium sulphite is an impurity resulting from the starting material. BLANCOLE HP can be obtained by a similar reaction as a mono-constituent substance. Especially in aqueous media, disodium hydroxysulfinateacetate of BRUGGOLITE FF6 is easily oxidized; the primarily resulting product is disodium hydroxysulfonateacetate. Therefore, practically no significant differences will occur between testing of BRUGGOLITE FF6 and BLANCOLEN HP in aqueous systems if any contributions of sodium sulphite to the result can be neglected. Moreover disodium hydroxysulfinateacetate is the stronger reducing agent and is expected to induce more severe effects compared to the hydroxysulfonateacetate.

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)
Principles of method if other than guideline:
Occupational Medical Assessment
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material is BRUGGOLITE FF6

Test animals

Species:
human
Sex:
male

Administration / exposure

Route of administration:
inhalation: dust
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
not applicable
No. of animals per sex per dose:
not applicable

Results and discussion

Applicant's summary and conclusion