Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well-documented and acceptable for assessment.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
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
Details on test animals and environmental conditions:
no data

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
Details on study design:
MAIN STUDY
The test substance was suspended in 40% propylene glycol in order to improve viscosity and assure stability of the concentrations

A. INDUCTION EXPOSURE
- No. of exposures: 10 intradermal injections
- Exposure period: 3 weeks
- Test groups: test substance in Freund's adjuvent (during the 2nd and 3rd week)
-2 control groups: NaCl, 40% propylene glycol


B. CHALLENGE EXPOSURE
- Day(s) of challenge:
- Exposure period: 2 weeks after 1 intradermal injection and 24 h after epidermal application (occlusive)
- Test groups: test substance in 40% propylene glycol
- 2 control groups: NaCl, 40% propylene glycol
- Evaluation (hr after challenge): 1 week after epidermal application

OTHER:

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 with iron oxides: FeO.Fe2O3 (iron oxide black), Fe2O3 iron oxide red and iron oxide yellow Fe2O3xH2O in guinea 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 as a dermal sensitizer.