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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
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:
study report
Title:
Unnamed
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
diiron trioxide mixture
IUPAC Name:
diiron trioxide mixture
Constituent 2
Reference substance name:
Bayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%)
IUPAC Name:
Bayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Two patches were shaved, one served as a control
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: each animal was evaluated individually
Time point:
other: 1, 24, ,48, 72 and 168 hrs
Score:
0
Max. score:
0
Remarks on result:
other: No effects found at at any time point for any animal
Irritation parameter:
edema score
Basis:
other: each animal was evaluated individually
Time point:
other: 1, 24, 48, 72 and 168 hrs
Score:
0
Max. score:
0
Remarks on result:
other: No edema was observed on any animal at any point in time
Other effects:
not observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Bayferrox VP AC 5122 M-Investigation of its primary irritation/corrosion on the rabbit skin. The test material is not irritating.
Executive summary:

In a primary dermal irritation study 3 New Zealand white rabbits were dermally exposed to500 mgofBayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%) inwaterfor4hours. Animals then were observed for7days. The study was performed according to the OECD Guidelines 404 for acute dermal irritation/corrosion.Bayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%) did not causedermal irritation.