Registration Dossier
Registration Dossier
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EC number: 266-007-8 | CAS number: 65996-74-9 The oxidized surface of steel produced during reheating, conditioning, hot rolling, and hot forming operations. This substance is usually removed by process waters used for descaling, roll and material cooling, and other purposes. It is subsequently recovered by gravity separation techniques. Composed primarily of high-purity iron oxides. May contain varying amounts of other oxides, elements, and trace compounds.
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:
- 1 984
- 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
- 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
Constituent 1
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
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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.
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