Iron manganese trioxide

Endpoint summary

Description of key information

In an oral acute toxicity study 10 animals were treated with 10000 mg/kg bw (Fe,Mn)3O4 (CAS 68186-94-7) as a surrogate for (Fe,Mn)2O3. During an observation time of 14 days none of the animals showed signs of toxicity or died. In an acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. No study for acute dermal toxicity is available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and sufficient documented

Justification for type of information:

see attachment "Endpoint-specific read-across justification for the iron oxide category" in IUCLID section 13.2.

Reason / purpose for cross-reference:

read-across source

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Clinical signs:

other:

Interpretation of results:

GHS criteria not met

Executive summary:

10 animals were treated with 10000 mg/kg bw of the test substance. During an observation time of 14 days none of the animals showed signs of toxicity or died.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

10 000 mg/kg bw

Quality of whole database:

scientifically acceptable and sufficient documented

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of 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: as reported in source record

Justification for type of information:

see attachment "Endpoint-specific read-across justification for the iron oxide category" in IUCLID section 13.2.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Duration of exposure:

4 h

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

5.05 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Executive summary:

Five male and 5 female Wistar rats were exposed single to 5 mg/l CERAC-Pigment (average particle size = 35 nm) for 4 hours. The animals were observed for mortality, clinical signs and body weight during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.

Following a single snout only inhalation exposures to CERAC-Pigment for four hours at an aerosol concentration of 5 mg/L, all animals tolerated the exposure. The Median Lethal Concentration (MLC) was therefore considered to be in excess of 5 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5 050 mg/m³ air

Quality of whole database:

GLP guideline study

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

other:

Clinical signs:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are no data available on acute toxicity of (Fe,Mn)2O3. As demonstrated in the category approach justification, in regard to structure, physicochemical properties, environmental fate characteristics, ecotoxicity and toxicity, the grouping of Fe2O3 (diiron trioxide), Fe3O4 (triiron tetraoxide), FeOOH (iron hydroxide oxide), (Fe,Mn)2O3 (iron manganese trioxide), (Fe,Mn)3O4 (manganese ferrite), and ZnFe2O4 (zinc ferrite) in the "Iron Oxides Category" is justified (for further details see Category justification document).

In a reliable acute toxicity studies rats received per gavage doses of 10000 mg (Fe,Mn)3O4/kg bw. Neither symptoms nor mortality were observed. Therefore the discriminating dose is > 10000 mg/kg bw.

In an acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. No study for acute dermal toxicity is available. Due to its structure and physico-chemical properties (insoluble in water and organic solvents) no systemic bioavailability is expected.

Justification for selection of acute toxicity – oral endpoint

Key study is used

Justification for selection of acute toxicity – inhalation endpoint

key study is used

Justification for classification or non-classification

In a reliable acute toxicity studies rats received per gavage doses of 10000 mg (Fe,Mn)3O4/kg bw. Neither symptoms nor mortality were observed. Therefore the discriminating dose is > 10000 mg/kg bw.

In an acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. No study for acute dermal toxicity is available. Due to its structure and physico-chemical properties (insoluble in water and organic solvents) no systemic bioavailability is expected.

A classification is not required.