Slags, steelmaking, vanadium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-05-18 to 2010-06-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study reliable without restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

, 2002-04-24

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2009-11-12

Test material

Test material information

Constituent 1

Reference substance name:

Slags, steelmaking, vanadium

EC Number:

273-734-4

EC Name:

Slags, steelmaking, vanadium

Cas Number:

69012-34-6

Molecular formula:

Substance is a UVCB in mineral form, therefore provision of molecular formula is not technically feasible

IUPAC Name:

Slags, steelmaking, vanadium

Details on test material:

- Name of test material (as cited in study report): Slags, steelmaking, vanadium (TIAG)
- Trivial name: V slag
- Physical state: Solid, black powder
- Storage condition of test material: Kept dry in tightly sealed containers
- Melting point: >1200°C
- Water solubility: Insoluble
- Relative density: 1.9 - 2.2
No further information on the test material was stated.

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: Approx. 3 - 5 months
- Weight at study initiation: Animal 1: 2.3 kg; Animal 2: 2.4 kg; Animal 3: 2.1 kg
- Housing: For 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine. During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany).
- Diet (ad libitum): Commercial diet, ssniff7 K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum before and after the exposure period): Tap water
- Acclimation period: At least 20 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C +/- 3 °C (maximum range)
- Relative humidity: 30% - 70% (maximum range; aim was 50% - 60%)
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item were administered into one eye each of three animals. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
No further infromation on the amount/concentration applied was stated.

Duration of treatment / exposure:

1 hour (One hour after application the eyes were rinsed.)

Observation period (in vivo):

1, 24, 48 and 72 hours and 4 to 6 days after the administration

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

It is explicitly noted and in accordance with the guideline used, that the test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were rinsed with portions of 20 mL 0.9 % aqueous NaCl solution, each.
- Time after start of exposure: 1 hour after administration

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours and 4 to 6 days after the administration. The eye reactions were observed and registered.
24 hours after administration, fluorescein (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany)) was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.

OTHER OBSERVATIONS: Any further lesions not covered by the scoring system were recorded. Body weight of all animals was measured at the beginning of the study and at the end of the study. Behaviour and food consumption were monitored.
No further information on the study design was stated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

Conjunctival redness (grade 1 (Some blood vessels hyperaemic (injected)) or grade 2 (diffuse, crimson colour; individual vessels not easily discernible)) was observed in all animals 60 minutes and 24 hours after instillation, in animal no. 3 until 5 days after instillation. The mean score in one of the three animals, following grading at 24, 48 and 72 h after instillation of the test material, was calculated as 2, the other two animals show effects which result in a mean score of 0.33. The effects were reversible within 6 days.
Chemosis (grade 1 (some swelling above normal)) was observed in animal no. two 60 minutes after instillation.
In addition, secretion was observed in animal no. three 60 minutes to 72 hours after instillation.
The corneae and the irises were not affected by instillation of the test item.
The fluorescein test performed 24 hours after instillation did not reveal any changes.
There were no systemic intolerance reactions.

Other effects:

There were no systemic intolerance reactions.

Any other information on results incl. tables

The irritation results (means) are summarized as follows:

Opacity (cornea and iris), 1h after application: mean score=0.0

Conjunctival chemosis, 1h after application: mean score=0.33

Conjunctival chemosis, 24, 48 and 72h after application: mean score=0.0

Conjunctival redness, 1h after application: mean score=1.33

Conjunctival redness, 24, 48 and 72h after application: mean score=0.66

Conjunctival redness, 6d after application: mean score=0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions slags, steelmaking, vanadium (TIAG) is non-irritating to eyes, hence, no labelling is required.
Also, according to the EC Regulation 1272/2008 and subsequent regulations, the test item is non-irritating due to the fact that only one animal of three shows conjunctivae redness with a mean score of 2.