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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Mill scale is mainly and primarily composed of high-purity iron oxides (on average above 65%, i.e. FeO, Fe2O3, Fe3O4). Besides, other metal oxides and spinels, elements, and trace compounds such as oil residues <1% for all the uses except for batteries and Melting charge for which <3% can be found in the mill scale. More information on the justification of read across can be found in the attached document in the endpoint summarie of section 7.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Prädikative Evaluierung allergener Wirkungen von Arznei- und Färbemitteln im Tierexperiment
Author:
Maurer T
Year:
1979
Bibliographic source:
Acta Pharm Technol Suppl 8, 37-44

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Guinea pig Optimization Test. Number of animals: 20 (Induction) : 10 intradermal injections of a 0.1 % test preparation during the first 3 weeks. A 2-week rest period follows and threafter, intradermal challenge (6th week), which is followed again by epidermal challenge 10 days later. Evaluation parameters: skin fold thickness, erythema.
GLP compliance:
not specified
Remarks:
It is not customary to refer to GLP compliance in publications.
Type of study:
Maurer optimisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Diiron trioxide
EC Number:
215-168-2
EC Name:
Diiron trioxide
Cas Number:
1309-37-1
Molecular formula:
Fe2O3
IUPAC Name:
diiron trioxide
Constituent 2
Reference substance name:
iron(III) oxide
IUPAC Name:
iron(III) oxide
Constituent 3
Chemical structure
Reference substance name:
Triiron tetraoxide
EC Number:
215-277-5
EC Name:
Triiron tetraoxide
Cas Number:
1317-61-9
Molecular formula:
Fe3O4
IUPAC Name:
iron(II) diiron(III) oxide
Constituent 4
Reference substance name:
iron(II,III) oxide
IUPAC Name:
iron(II,III) oxide
Constituent 5
Reference substance name:
Goethite (Fe(OH)O)
EC Number:
215-176-6
EC Name:
Goethite (Fe(OH)O)
Cas Number:
1310-14-1
IUPAC Name:
1310-14-1
Constituent 6
Reference substance name:
iron oxide yellow
IUPAC Name:
iron oxide yellow
Details on test material:
FeO.Fe2O3 (iron oxide black), Fe2O3 iron oxide red and iron oxide yellow Fe2O3xH2O
No further information available on the test material, no data on purity.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Freund's adjuvant during the 2nd and 3rd week of induction
Concentration / amount:
0.1 % test preparation
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's adjuvant during the 2nd and 3rd week of induction
Concentration / amount:
0.1 % test preparation
No. of animals per dose:
20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: after intradermal challenge
Group:
other: test goup: iron oxide black
Dose level:
0.1%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: other: after intradermal challenge. Group: other: test goup: iron oxide black. Dose level: 0.1%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
other: after intradermal challenge
Group:
other: control 40% propylene glycol
Dose level:
0.1%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: other: after intradermal challenge. Group: other: control 40% propylene glycol. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
other: after intradermal challenge
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: after intradermal challenge. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: after intradermal challenge
Group:
other: tets group iron oxide red
Dose level:
0.1%
No. with + reactions:
11
Total no. in group:
20
Remarks on result:
other: Reading: other: after intradermal challenge. Group: other: tets group iron oxide red. Dose level: 0.1%. No with. + reactions: 11.0. Total no. in groups: 20.0.
Reading:
other: after intradermal challenge
Group:
other: test group iron oxide yellow
Dose level:
0.1%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: other: after intradermal challenge. Group: other: test group iron oxide yellow. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 20.0.
Reading:
other: after epidermal challenge
Group:
other: control 40% propylene glycol
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: other: after epidermal challenge. Group: other: control 40% propylene glycol. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
other: after epidermal challenge
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: after epidermal challenge. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: after epidermal challenge
Group:
other: test group iron oxide black
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: other: after epidermal challenge. Group: other: test group iron oxide black. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 19.0.
Reading:
other: after epidermal challenge
Group:
other: iron oxide red
Dose level:
0.1%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: other: after epidermal challenge. Group: other: iron oxide red. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
other: after epidermal challenge
Group:
other: test group iron oxide yellow
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: after epidermal challenge. Group: other: test group iron oxide yellow. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
All three iron oxides can be considered as non sensitizing
Executive summary:

In a dermal sensitization study withiron oxides: FeO.Fe2O3 (iron oxide black), Fe2O3 iron oxide red and iron oxide yellow Fe2O3xH2O inguinea pigs. The animals were intradermally injected 10 times with a 0.1 % test preparation, in a period of 3 weeks.In the second and third week Freund's adjuvant was used as vehicle. A 2-week rest period follows and threafter, intradermal challenge (6th week), which is followed again by epidermal challenge 10 days later. Evaluation parameters were skin fold thickness and erythema. The results were deemed as negative. In this study,all three iron oxides are not considered asa dermal sensitizer.

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