Dust, steelmaking

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8.2.2010-12.2.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dust, steelmaking

EC Number:

266-005-7

EC Name:

Dust, steelmaking

Cas Number:

65996-72-7

IUPAC Name:

Dust steelmaking

Details on test material:

- Physical state: solid
- Composition of test material, percentage of components: Fe total 57.64% (mainly as oxides), CaO 8.89%, Zn 4.16%, MgO 3.64%, C 0.69%, SiO2 1.56%, Mn 0.57 %, K2O 0.281%, Na2O 0.251%, Al2O3 0.18%
- Lot/batch No.: 21.10.2009
- Expiration date of the lot/batch: unlimited
- Storage condition of test material: stored in PE container at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ, s.r.o., Kolec u Kladna, Czech republic
- Age at study initiation: 4-5 months
- Weight at study initiation: 3.3-3.6 kg
- Housing: individually in cages without bedding in conventional animal room
- Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits ang guinea-pigs ad libitum (producer: Ing. Mrkvicka Miroslav - Výroba krmných smesí, Mlýn Kocanda, Jesenice u Prahy)
- Water (e.g. ad libitum): drinking tap water ad libitum (quality corresponding to regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C (permanently monitored)
- Humidity (%): 30-70 % (permanently monitored)
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3 rabbits (female)

Details on study design:

TEST SITE
- Area of exposure: 6×6 cm
- Type of wrap if used: the test substance in the dose of 0.5 g was applied on intact skin and then it was covered by gauze patch and cellulose cotton and held in place with non-irritating tape - Spofaplast


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 3 min, 1 hour and 4 hours


SCORING SYSTEM:
Erythema:
0 - no erythema
1 - very slight erythema (barely perceptible)
2 - well defined erythema
3 - moderate to severe erythema
4 - severe erythema (beet redness) to eschar formation preventing grading of erythema

Oedema:
0 - no oedema
1 - very slight oedema (barely perceptible)
2 - slight oedema (edges of area well defined by definite raising)
3 - moderate oedema (raise approximatey 1 mm)
4 - severe oedema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: No. 10

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal: No. 11

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal: No. 12

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal: No. 10

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal: No. 11

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal: No. 12

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no evidence of a corrosive effect on the skin.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
No histopathology was performed.

Any other information on results incl. tables

Table 1: Result of initial test

exposure time	observation
3 minutes	no erythema, no oedema
1 hour	no erythema, no oedema
4 hours	no erythema, no oedema

Table 2: Skin reactions in experimental animals

time after 4-hours exposure	rabbit No.
	10	11	12
1 hour	erythema 0 oedema 0	erythema 0 oedema 0	erythema 0 oedema 0
24 hours	erythema 0 oedema 0	erythema 0 oedema 0	erythema 0 oedema 0
48 hours	erythema 0 oedema 0	erythema 0 oedema 0	erythema 0 oedema 0
72 hours	erythema 0 oedema 0	erythema 0 oedema 0	erythema 0 oedema 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure. No symptoms of systemic toxicity were observed in the animals during the test period.
No skin irritation was caused by 4-hour exposure to Dust, steelmaking.

Executive summary:

The test substance, Dust, steelmaking, was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test. Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure.

At first the test substance was applied on the skin of one rabbit. Rabbit was investigated 3 minutes, 1 hour and 4 hours after application of the test substance. No symptoms of irritation were observed on the skin. In confirmatory test, two others rabbits were used with 4-hour exposition period. No evidence of a corrosive effect or symptoms of irritation were observed on the skin.

No skin irritation was caused by 4-hour exposure toDust, steelmaking. No other signs of intoxication were observed.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC, Annex VI, part 3.2.6.1.), the test substance Dust, steelmaking does not have to be classified for skin irritation and has no obligatory labelling requirement for skin irritation.