Calcium-Silicium-Magnesium-Aluminium-Iron-Manganese oxide equivalent

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Slags, steelmaking, elec. furnace (stainless/high alloy steel production - EAF S)

IUPAC Name:

Slags, steelmaking, elec. furnace (stainless/high alloy steel production - EAF S)

Constituent 2

Reference substance name:

Slags, steelmaking, elec. furnace

EC Number:

294-410-9

EC Name:

Slags, steelmaking, elec. furnace

Cas Number:

91722-10-0

Molecular formula:

not applicable because slags are UVCB

IUPAC Name:

294-410-9

Details on test material:

Slag, steelmaking, elec. furnace (stainless/high alloy steel production – EAF S), fine-ground

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

3 female Albino rabbits from Elevage de Gérome, Quartier Labaste, F40260 Linxe
Weight 2.17-3.52 kg/animal during test, 11 to 15 weeks old
5 d acclimatization
17- 23 °C
relative humidity 30 - 70 % saturation

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

main test 0.5 g/animal (6 cm2)

Duration of treatment / exposure:

4 h

Observation period:

Documentation of observations after
1 h
24 h
48 h
72 h

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

ca. 0.7

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

0

Reversibility:

other: no observable effect

Remarks on result:

other: Since no effect persisted, observation terminated after 72 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h, 24 h, 48 h, 72h

Score:

0

Max. score:

0

Reversibility:

other: not relevant because no irritation/corrosion occured

Remarks on result:

other: Since no effect occurred, observation terminated after 72 h

Irritant / corrosive response data:

No relevant irritative effect observed. No relevant hazard detected during test.

Other effects:

none

Any other information on results incl. tables

Classification

The numerical scores obtained in each rabbit on assessing irritation caused by the test material at the twenty four, forty eight, and seventy two hour observations were summed and a mean calculated. The values for erythema and eschar formation remained separate from those obtained on evaluating edema. When the mean value obtained for either erythema or edema equalled or exceeded two, in two or more animals, then the material was considered an irritant.

No relevant irritation/corrosion was observed, and the slag has not to be classified

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

EAF S: OECD TG 404, rabbits: neither irritating nor corrosive to skin

Executive summary:

To test the irritative potential of slags, steelmaking, elec. furnace (stainless/high alloy steel production – EAF S) to skin, tests were performed following OECD guideline 404 and the almost identical test method, B.4 of the Council Regulation 440/2008. Fine-ground EAF S was dosed, in its original form, at 0.5 g/animal under semi-occlusive dressing during 4 h to an undamaged skin area of each 6 cm2 of 3 female albino rabbits. After dosing, the patches were removed and skin reaction to the test material was assessed after 1 h, 24 h, 48 h, and 72 h. As no irritation was observed during 72 h, observation was terminated.

Slags, steelmaking, elec. furnace (stainless/high alloy steel production - EAF S) are neither irritating nor corrosive. EAF S do not need to be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the EU Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (Regulation (CE) No 1272/2008), the slags do not need to be classified. Neither a signal word nor a hazard statement are required.