Mill scale (ferrous metal)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

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 summaries of section 7.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Single oral application by gavage, post observation time: 14 days, test substance was applicated in water

GLP compliance:

not specified

Remarks:

The study was performed before the adoption of GLP principles

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

iron(III) oxide

IUPAC Name:

iron(III) oxide

Constituent 2

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

Details on test material:

- Name of test material (as cited in study report): alpha-Fe2O3, ferric oxide
- Molecular formula (if other than submission substance): Fe2O3
- Analytical purity: 96.2%
-Density: 5 g/ml

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results Fe2O3 is practically non toxic, because no mortality or abnormalities were observed in 10 rats exposed orally to 10000 mg/kg bw.

Executive summary:

In an acute oral toxicity study, male Wistar rats were given a single oral dose of alpha-Fe2O3 in water at a dose of  10000  mg/kg bw (limit test); the treatment was followed by 14 days of observation. No control animals were used in this study. No mortality and clinical abnormalities were observed. The study yielded an oral LD50 of > 10000 mg/kg bw for male rats. Ferric oxide is practically non toxic based on the results of this study, and classification and labelling for acute oral toxicity is not required.