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EC number: 266-005-7 | CAS number: 65996-72-7 The dust generated during the charging, operation, and tapping of a steelmaking furnace and from steel conditioning, including that which is recovered through the use of pollution abatement equipment. Composed primarily of iron oxides. May contain varying amounts of other metallic oxides and trace compounds.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22.2.2010-3.3.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- 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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: 3.2-3.6 kg
- Housing: conventional animal room - individually in metallic cages
- Diet (e.g. ad libitum): standard pelleted diet TM-MAK 1 for rabbits and 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 the Regulation No.: 252/2004 Czech Coll. of Law)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C (permanently monitored)
- Humidity (%): 30-70 % (permanently monitored)
- Photoperiod (hrs dark / hrs light): 12 hr light / 12 hr dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours
next every day till 8th day - Number of animals or in vitro replicates:
- 3 rabbits (male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: see legend at next window
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1 - 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1 - 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1 - 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2 - 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- see Table 1
Any other information on results incl. tables
Table 1: Results of acute eye reaction
| Animal No. | Ocular lesions | Time interval of examination | |||
| 1 h | 24 h | 48 h | 72 h | ||
| 4 | Cornea | 0 | 1 | 0 | 0 |
| Iris | 0 | 0 | 0 | 0 | |
| Conjunctivae | 2 | 2 | 1 | 1 | |
| Chemosis | 2 | 3 | 1 | 1 | |
| 5 | Cornea | 0 | 0 | 1 | 1 |
| Iris | 0 | 0 | 0 | 0 | |
| Conjunctivae | 2 | 2 | 2 | 2 | |
| Chemosis | 2 | 2 | 3 | 3 | |
| 6 | Cornea | 0 | 1 | 1 | 0 |
| Iris | 0 | 0 | 0 | 0 | |
| Conjunctivae | 2 | 2 | 1 | 1 | |
| Chemosis | 2 | 2 | 1 | 1 | |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information reversible Criteria used for interpretation of results: EU
- Conclusions:
- The changes described further were observed on eye of animals. The effects were detected at all three animals at 1 hour after application, and persisted till 7th day after application.
Changes at 1 hour after application: in all animals strong lacrimation, redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – obvious swelling with partial eversion of lids.
Changes at 24 hours after application: in all animals lacrimation, redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – obvious swelling with partial eversion of lids in two animals and chemosis – swelling with lids about half closed in one animal, cornea - diffuse areas of opacity, detail of iris clearly visible in two animals.
Changes at 48 hours after application: in one animal redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – swelling with lids about half closed, cornea - diffuse areas of opacity, detail of iris clearly visible.
Changes at 72 hours after application: redness of conjunctivae – some blood vessels hyperaemic (injected) and chemosis – some swelling above normal.
Changes in all animals completely faded away till 8th day after application.
No clinical signs of systemic intoxication were detected.
Examination of eye irritation after single application demonstrated, that the test substance, Dust, steelmaking, is irritating for eye of rabbit; the changes observed are reversible.
The classification of the test substance eye irritation/corrosion effect was performed according to Directive 67/548/EEC, Annex VI.
Based on the test results and according to the EC criteria for classification and labelling of dangerous substances and preparations the test substance does not have to be classified for eye irritation/corrosion and has no obligatory labelling requirement for eye irritation/corrosion. - Executive summary:
The test substance, Dust, steelmaking, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).
The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test was performed initially using one animal. Because a corrosive effect was not observed in initial test, the response was confirmed using two additional animals.
The changes described further were observed on eye of animals. The effects were detected at all three animals at 1 hour after application, and persisted till 7th day after application.
Changes at 1 hour after application: in all animals strong lacrimation, redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – obvious swelling with partial eversion of lids.
Changes at 24 hours after application: in all animals lacrimation, redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – obvious swelling with partial eversion of lids in two animals and chemosis – swelling with lids about half closed in one animal, cornea - diffuse areas of opacity, detail of iris clearly visible in two animals.
Changes at 48 hours after application: in one animal redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – swelling with lids about half closed, cornea - diffuse areas of opacity, detail of iris clearly visible.
Changes at 72 hours after application: redness of conjunctivae – some blood vessels hyperaemic (injected) and chemosis – some swelling above normal.
Changes in all animals completely faded away till 8th day after application.
No clinical signs of systemic intoxication were detected.
Examination of eye irritation after single application demonstrated, that the test substance, Dust, steelmaking, is irritating for eye of rabbit; the changes observed are reversible.
The classification of the test substance eye irritation/corrosion effect was performed according to Directive 67/548/EEC, Annex VI.
Based on the test results and according to the EC criteria for classification and labelling of dangerous substances and preparations the test substance does not have to be classified for eye irritation/corrosion and has no obligatory labelling requirement for eye irritation/corrosion.
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