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Description of key information

Several in vitro and in vivo tests on ferrous slags demonstrate that these slags have no irritant and no corrosive potential to skin and eye. No classification is required.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

13 studies on the irritation/corrosion potential to skin of ferrous slags are available.

In vitro skin irritation tests

4 GLP guideline studies were performed on ferrous slags to determine their skin irritation/corrosion potential in vitro.

2 Studies deal with slags, steelmaking, elec. furnace (carbon steel production - EAF C) and slags, steelmaking, elec. furnace (stainless/high alloy steel production - EAF S), which were fine ground and tested in the Human Skin Model Test following OECD 431. One valid experiment was performed for each slag as follows:

Two tissues of the human skin model EpiDermTM were treated with fine-ground EAF S for 3 min and 1 h, respectively. 25 mg of the solid test item were applied to each tissue, wetted with H2O and spread to match the tissue size. Deionised water was used as negative control. 8 mol/L KOH was used as positive control.

After treatment with the negative control, the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus demonstrating the metabolic activity of the tissues. The positive control showed clear corrosive effects for both treatment intervals.

After three minutes treatment with the slags, the relative absorbance values were slightly reduced but well above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values were not further decreased and well above the threshold for corrosion potential (15%).

2 similar studies were performed with slags, steelmaking, converter (BOS) and slags, steelmaking (SMS). The fine ground material was leached with a L/S (liquid/solid) of 5/1, and the leachate tested in the Human Skin Model Test following OECD 431. Again, one valid experiment was performed for each slag, and the results indicated that also neither BOS nor SMS are corrosive to skin (LAUS GmbH 2010a and b).

 

In vivo skin irritation tests

9 studies on the irritant potential of slags to skin, tests were identified in the literature or were performed with slags as a basis for category justification and verification of slags identity and sameness with negatively tested ferrous slags.

3 studies were done according to OECD guideline 404 either with fine-ground slags, ferrous metal, blast furnace (air cooled – ABS) (Toxicol Laboratories 1990), slags, steelmaking, elec. furnace (carbon steel production - EAF C) (Phycher 2010) and slags, steelmaking, elec. furnace (stainless/high alloy steel production – EAF S) (Phycher 2010). The fine-ground slags were dosed, in its original form, at 0.5 g/animal under semi-occlusive dressing during 4 h to an undamaged, dorsal skin area of each 6 cm2of 3 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. No relevant irritation was observed during 72 h in any of the slags (ABS/GBS, EAF C and EAF S).

2 similar studies were performed with slags, steelmaking, converter (BOS) and slags, steelmaking (SMS). The fine ground material was leached with a L/S (liquid/solid) of 5/1, and the leachate tested according to OECD guideline 404. Again, one valid experiment was performed for each slag, and the results indicated that also neither BOS nor SMS are irritant to skin (CONFARMA2010a and b).

Another 3 studies tested the irritant and corrosive potential to skin of slags, steelmaking, converter (BOS), slags, steelmaking (SMS), and crushed stone from a quarry in the vicinity of Serra () also following OECD guideline 404 with the fine-ground test material. The test items, BOS, SMS and crushed stone, were neither corrosive nor irritant to the skin (Reis da Silva et al. 2007).

Another 2 studies cover the skin irritation potential of 4 ferrous slags in mixtures of 2 slags each. One study covers a mixture of both EAF C and EAF S (EAF C/EAF S), the other study covers a mixture of BOS and SMS (BOS/SMS). Also these studies were performed following OECD TG 404 using fine-ground slags. The majority of the animals studied showed slight reddening of the skin, possibly due to elevated pH, which was fully reversible in all animals after 72h. So no relevant irritation potential leading to classification was observed for any of these mixtures (Central Mining Institute 2005).

 

Thus, ABS/GBS, BOS, EAF C, EAF S and SMS are neither irritant nor corrosive to the skin in vivo.

 

14 studies on the irritation/corrosion potential to eye of ferrous slags are available. 12 studies were taken into account, 2 studies were not assignable and disregarded.

 

In vitro eye irritation tests

5 GLP guideline studies were performed on ferrous slags to determine their eye irritation/corrosion potential in vitro.

3 Studies deal with slags, ferrous metal, blast furnace (air cooled – ABS), slags, steelmaking, elec. furnace (carbon steel production - EAF C) and slags, steelmaking, elec. furnace (stainless/high alloy steel production - EAF S), which were fine ground and tested in theHET-CAMTest following ICCVAM recommended test method protocol. One valid experiment was performed for each slag, and the results indicated that none of the slags possesses no irritation potential(LAUS 2009a, b and c).

2 studies were performed with slags, steelmaking, converter (BOS) and slags, steelmaking (SMS). The fine ground material was leached with a L/S (liquid/solid) of 5/1, and the leachate tested in the BCOP Test following OECD 437. Again, one valid experiment was performed for each slag, and the results indicated that also neither BOS nor SMS possesses no irritation potential (LAUS 2010a and 2011).

 

In vivo eye irritation tests

7 studies on the irritant potential of slags to the eye were identified in the literature or were performed with slags as a basis for category justification and verification of slags identity and sameness with negatively tested ferrous slags. Two further studies (Reis da Silva JB et al. 2006; Reis da Silva JB et al. 2007) were not assignable and disregarded.

2 studies were done according to OECD guideline 405 either with fine-ground slags, ferrous metal, blast furnace (air cooled – ABS) (Phycher (Richeux F) 2010a)and slags, steelmaking, elec. furnace (carbon steel production - EAF C) (Phycher (Richeux F)2010b). The fine-ground slags were instilled, in its original form, into the eye of Zew Zeeland rabbits (three per slag) at the dose of 0.1 g/animal. The ocular conjunctivae reactions observed during the study have been slight to moderate and totally reversible in the animals.

3 similar studies were performed with slags, steelmaking, elec. furnace (stainless/high alloy steel production – EAF S)) (Phycher (Colas S)2010), slags, steelmaking, converter (BOS) and slags, steelmaking (SMS) (CONFARMA2010c and d). The fine ground material was leached with a L/S (liquid/solid) of 5/1, and the leachate tested according to OECD guideline 405. Again, one valid experiment was performed for each slag, and the results indicated that also neither EAF S nor BOS nor SMS are corrosive to eye.

Another 2 studies cover the eye irritation potential of 4 ferrous slags in mixtures of 2 slags each. One study covers a mixture of both EAF C and EAF S (EAF C/EAF S), the other study covers a mixture of BOS and SMS (BOS/SMS). Also these studies were performed following OECD TG 405 using fine-ground slags.

All animals showed slight reddening of the conjunctivae, possibly due to elevated pH and/or mechanical effects, which was fully reversible in all animals after 7 d. Cornea and iris were not affected. So no relevant eye irritation potential leading to classification was observed for any of these mixtures (Central Mining Institute 2005).

 

Thus, ABS/GBS, BOS, EAF C, EAF S and SMS are neither irritant nor corrosive to the eye in vivo.

Justification for classification or non-classification

No relevant irritant or corrosive effects on test organisms were exerted by slags, and no classification is required.