Iron ores, agglomerates

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study carried out according to OECD guideline 404 well documented and scientifically acceptable

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:

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

Test material information

Constituent 1

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%)

Constituent 2

Reference substance name:

iron(III) oxide mixture

IUPAC Name:

iron(III) oxide mixture

Details on test material:

Bayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were male rabbits, new zealand white. They weighed between 3 and 4 kg and were kept in separate cages at a temperature between 19 and 25oC and a relative humidity between 40 and 60%. The day/night rhytm was 12/12 hours. The animals were fed with a standard diet and were allowed to drink tap water ad libitum.

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.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3

Details on study design:

The study was carried out according to guideline 404. The skin of three male white rabbits was exposed to 500 mg Bayferrox VP AC 5122. This was applied semi-occlusive to a patch of shaved skin. A second patch of shaved skin was used as a control. Exposure was for 4 hours and after exposure the skin was rinsed with water.

Results and discussion

In vivo

Results

Results 1

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 efects found at at any time point for any animal

Results 2

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 to 500 mg of Bayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%) in water for 4 hours. Animals then were observed for 7 days. 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 cause dermal irritation.