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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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: detailed report available
Principles of method if other than guideline:
Number of animals: 20
Induction: 10 intradermal injections of a 0.1 % test preparation in 3 weeks. In the second and third week Freund's adjuvant is used as vehicle.
Thereafter a 2-week rest period is followed by intradermal challenge, which is followed again by epidermal challenge 10 days later.
Evaluation parameters: skin fold thickness, erythema
GLP compliance:
not specified
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:
intradermal
Vehicle:
no data
Concentration / amount:
10 intradermal injections of a 0.1 % test preparation in
Route:
intradermal and epicutaneous
Vehicle:
no data
Concentration / amount:
10 intradermal injections of a 0.1 % test preparation in
No. of animals per dose:
20
Reading:
1st reading
Hours after challenge:
336
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
11
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: 11.0. 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:
4
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 504.0. Group: test group. Dose level: maximum subirritant dose. No with. + reactions: 4.0. Total no. in groups: 20.0.
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:

10 intradermal injections of a 0.1 % test preparation in 3 weeks. In the second

and third week Freund's adjuvant is used as vehicle. Thereafter a 2-week rest

period is followed by intradermal challenge, which is followed agin by epidermal

challenge 10 days later.

Evaluation parameters: skin fold thickness, erythema

result: negative (the positive reactions are considered as a unspecific foreign particle reaction)

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

For Fe2O3, Fe3O4 and FeOOH no skin sensitisation potential was found. Data for skin sensitisation are not available for ZnO and Mn3O4. From human experience such an effect is unknown. Therefore no sensitisation potential can be assumed for all group members, if the results are conveyed to other compounds of the group. Two tests on humans are not assignable.

Migrated from Short description of key information:

For skin sensitisation a Maurer optimisation test was conducted for Fe3O4, Fe2O3 and FeOOH

Justification for selection of skin sensitisation endpoint:

scientifically acceptable and well documented

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 ZnO where such an effect was not described in the scientific literature.

Migrated from Short description of key information:

no data

Justification for classification or non-classification

Based on the available data a classification is not justified.