Iron sinter

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Juli 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981-05-12

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triiron tetraoxide

EC Number:

215-277-5

EC Name:

Triiron tetraoxide

Cas Number:

1317-61-9

Molecular formula:

Fe3O4

IUPAC Name:

Iron oxide

Details on test material:

Bayferrox-schwarz 350: Fe3O4

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

3 male rabbits were used. The organisms were kept in single cages at temperatures between 19 and 25°C, a relative humidity of 40-60% and a day/night rythm of 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:

other: 0.2% Na-Polyacrylate, 0.1% Preventol D2 and water (remainder)

Controls:

other: Untreated patches of skin served as a control

Amount / concentration applied:

0.5 ml of the sample

Duration of treatment / exposure:

4 hours.

Observation period:

one,, 24, 48, 72 hours and 7 days

Number of animals:

3 males

Details on study design:

4 hours after the exposure the skin was rinsed with water

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no reaction on the skin for edema. For erythema the results were difficult to judge because the skin was blackened, though after careful observation no irritation marks could be found.

Other effects:

no

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Bayferrox-Schwarz was not irritating.
According to the EC-Regulation 1272/2008 and subsequent adaptations, the substance does not require classification as irritating to the skin.

Executive summary:

Undiluted Bayferrox Schwarz was applied to the shaved skin of three male rabbits (New Zealand White rabbits). Application was with patches and semiocclusive. After 4 hours the patches were removed and the skin was rinsed with water. After 1, 24, 48, 72 and 168 hours the animals were evaluated for erythema and edema; untreated skin on the same animal was used as a control.

There was no edema observed and erythema was difficult to evaluate because the skin turned black after the treatment. Nevertheless, no signs of irritation were observed. Bayferrox-Schwarz proved not to be irritating.

It was concluded that Bayferrox-Schwarz 350 fluessig was not irritating to the skin.