Registration Dossier

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Updated category Justification
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Category Approach Justification
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Principles of method if other than guideline:
Updated category approach justification

Test material

Constituent 1
Reference substance name:
Diiron trioxide
EC Number:
215-168-2
EC Name:
Diiron trioxide
Cas Number:
1309-37-1
Constituent 2
Reference substance name:
Triiron tetraoxide
EC Number:
215-277-5
EC Name:
Triiron tetraoxide
Cas Number:
1317-61-9
Constituent 3
Reference substance name:
Iron hydroxide oxide yellow
EC Number:
257-098-5
EC Name:
Iron hydroxide oxide yellow
Cas Number:
51274-00-1
IUPAC Name:
51274-00-1
Constituent 4
Reference substance name:
Iron manganese trioxide
EC Number:
235-049-9
EC Name:
Iron manganese trioxide
Cas Number:
12062-81-6
IUPAC Name:
12062-81-6
Constituent 5
Reference substance name:
Manganese ferrite black spinel
EC Number:
269-056-3
EC Name:
Manganese ferrite black spinel
Cas Number:
68186-94-7
IUPAC Name:
manganese ferrite black spinel
Constituent 6
Chemical structure
Reference substance name:
Zinc ferrite brown spinel
EC Number:
269-103-8
EC Name:
Zinc ferrite brown spinel
Cas Number:
68187-51-9
Molecular formula:
ZnFe2O4
IUPAC Name:
Zinc ferrite brown spinel

Results and discussion

Preliminary studies:
This update includes information on the size of test materials used in different experiments discusses and compares toxicity of nano- and micro-sized (poder) materials. Data are available on nano- and powder material on different endpoints (acute toxicity, irritation, repeated dose toxicity). Similar toxicity was observed for all endpoints.

The comprehensive experimental data on repeated dose inhalation toxicity on Fe2O3 (powderl), Fe3O4 (powder) and FeOOH (nano material) indicate that a read-across from micro-sized material (powder) to nano-sized material is implicitly conservative and scientifically justified based on the generic, overload dependent effects observed with nano- and micro-sized material (powder).

Main ADME results
Type:
other:
Results:
This update includes information on the size of test materials. Overall, comprehensive and sufficient data are available to conclude that nano- and micro-sized category members behave similar and no further testing is necessary.

Applicant's summary and conclusion

Executive summary:

This Updated Category Approach Justification includes additional information on nano- and/or powder material to justify that the category covers nano- and micro-sized materials.

Categories Display