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Toxicological information

Skin irritation / corrosion

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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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
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
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.