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Description of key information

For skin sensitisation a Maurer optimisation test was conducted for Fe3O4, Fe2O3 and FeOOH as surrogates for (Fe,Mn)3O4 -  all three compounds are not irritant to skin and eye, and have no skin sensitizing potential (for further details see category justification).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: main features of study described
Principles of method if other than guideline:
Test concentration : 0.1 % in 40% propylene glycol in water Induction:
10 intradermal injections in 3 weeks
Elicitation:
intradermal: injection 5 weeks after start of study
epidermal : occlusive, ca. 7 weeks after start of study
GLP compliance:
no
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
According to the REACH regluation (EC) No. 1097/2006, the LLNA test is the first-choice method for in vivo testing and in exceptional circumstances another test can be used. Since the study was carried out before the regulation entered into force and the Maurer optimisation test was an acceptable method for testing skin sensitisation at the time of study conduct, it is not justified to conducted an additional LLNA test due to animal welfare.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
other: 1st induction 0.1 % intracutaneous
Vehicle:
other: 40% propylene glycol in water
Concentration / amount:
0.1 %
Route:
other: 2nd challenge 0.1 % intracutaneous; 3rd challenge 0.1 % occlusive epicutaneous
Vehicle:
other: 40% propylene glycol in water
Concentration / amount:
0.1 %
No. of animals per dose:
19
Reading:
1st reading
Hours after challenge:
336
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 336.0. Group: test group. Dose level: 0.1%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
336
Group:
negative control
Dose level:
0.1%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 336.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
504
Group:
test chemical
Dose level:
maximum subirritant dose
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 504.0. Group: test group. Dose level: maximum subirritant dose. No with. + reactions: 0.0. Total no. in groups: 19.0.
Reading:
2nd reading
Hours after challenge:
504
Group:
negative control
Dose level:
maximum subirritant dose
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 504.0. Group: negative control. Dose level: maximum subirritant dose. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

Guinea pigs were treated according the following procedure (test concentration 0.1% in

propylene glycole/water).

Induction: 10 intradermal injections. Elucidation (intradermal) injection 5 weeks after

start of the study; (epidermal)occlusive, 7 weeks after start of the study. As a result

epicutan application of the test substance is not sensitising.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

For the representatives of the group members (Fe3O4, Fe2O3 and FeOOH) no skin sensitisation potential was found in Maurer optimisation tests with members of the Category.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

All group members of the iron oxide group are insoluble in water and inert. A sensitisation of the respiratory tract is not expected. This statement is supported by the human evidence on Fe2O3, Fe3O4, FeOOH and manganese oxides where such an effect was not described in the scientific literature.

Justification for classification or non-classification

Based on the available data a classification is not justified.