Calcium-Iron-Silicium-Magnesium-Manganese-Aluminium oxide equivalent

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Slags, steelmaking, elec. furnace (carbon steel production - EAF C)

IUPAC Name:

Slags, steelmaking, elec. furnace (carbon steel production - EAF C)

Constituent 2

Reference substance name:

Slags, steelmaking, elec. furnace

EC Number:

294-410-9

EC Name:

Slags, steelmaking, elec. furnace

Cas Number:

91722-10-0

Molecular formula:

not applicable

IUPAC Name:

294-410-9

Constituent 3

Reference substance name:

Slags, steelmaking, elec. furnace (stainless/high alloy steel production - EAF S)

IUPAC Name:

Slags, steelmaking, elec. furnace (stainless/high alloy steel production - EAF S)

Details on test material:

see 4.8.31a/b of this IUCLID

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Healthy young adult albino New Zealand strain rabbits
During the tests, the animals weighted between 2.8 and 3.4 kg/animal. The animals were 14 to 18 weeks old.
The animals are housed in individual wire floored stainless steel cages of dimensions 60 cm x 35 cm x 40 cm.
- Temperature: 20 - 22 ° C,
- Climate: Relative humidity from 35 % to 55 %, with circadian cycle 12 h day / 12 h darkness.
Drinking water (tap-water from public distribution system) and foodstuff were supplied ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Both eyes of each experimental animal provisionally selected for testing should be examined before testing starts. Animals showing eye irritation, ocular defects, or pre-existing corneal injury were not be used.
0.1 g slag was applied after grinding into a fine powder. The volume was measured after gently compacting it, e.g., by tapping the measuring container. If the solid test item has not been removed from the eye of the test animal by physiological mechanisms at the first observation time point of 1 h after treatment, the eye was rinsed with saline or distilled water

Duration of treatment / exposure:

The eyes were examined at 1, 24, 48, 72 and 168 h after test item application. Animals were kept on test no longer than necessary once definitive information was obtained. Animals showing continuing severe pain or distress would have been humanely killed without delay, and the item assessed accordingly. Animals with the following eye lesions post-instillation should be humanely killed: corneal perforation or significant corneal ulceration including staphyloma; blood in the interior chamber of the eye; grade 4 corneal opacity which persists for 48 h; absence of a light reflex (iridial response grade 2) which persists for 72 h; ulceration of the conjunctival membrane; necrosis of the conjunctivae or nictitating membrane; or sloughing.
Animals that do not develop ocular lesions may be terminated not earlier than 3 d post-instillation. Animals with mild to moderate lesions should be observed until the lesions clear, or for 21 days, at which time the study is terminated. Observations should be performed at 7, 14 and 21 d in order to determine the status of the lesions, and their reversibility or irreversibility.

The grades of ocular reaction (conjunctivae, cornae and iris) should be recorded at each examination. Any other lesions in the eye (e.g. pannus, staining) or adverse systemic effects would have also been reported.

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: observations

Basis:

other: 3 animals

Time point:

other: 1 h, 24 h, 48 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: lsee below

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

3 animals

Time point:

other: 168 h

Score:

0

Max. score:

0

Reversibility:

other: not relevant as no effect persisted

Remarks on result:

other: The authors point to Table 1 but this table is missing in the report. Therefore the full description of the intermediate effects is given below

Irritant / corrosive response data:

"Following administration of the test material, only conjunctival changes were observed in the rabbits' eyes.
In the assessment performed 1 hour after the administration, lupus was observed in the conjunctive of the rabbits' eyes: in rabbits 1 and 2 as conjunctival injection, and in rabbit 3 as diffuse crimson redness (individual vessels were poorly distinguishable). Pericorneal injection and third eyelid congestion were also observed in the three rabbits. Slight corneal oedema, third eyelid oedema and secretion on eyelids and eyelid hair were observed in the three rabbits.
In the assessment performed 24 hours after the administration, conjunctival injection was observed in rabbits 1 and 2, while diffuse crimson redness (individual vessels were poorly distinguishable) was observed in rabbit 3. Third eyelid congestion was observed in all three rabbits, while pericorneal injection was observed in one rabbit (no. 3). Slight conjunctival oedema was observed in rabbit 1, and slight third eyelid oedema in rabbits 2 and 3. In addition, small quantities of secretion were observed in all rabbits.
In the assessment performed 48 hours after the administration, same lesions as those observed after 24 hours were observed in the eyes of rabbits 1 and 2. Conjunctival lupus has been reduced - redness in the form of conjunctival injection, third eyelid congestion, pericorneal injection and small amounts of secretion were observed.
In the assessment performed 72 hours after the administration, redness expressed as conjunctival injection was still observed in the rabbit's eyes. In addition, third eyelid congestion and small quantities of secretion were observed in rabbits 2 and 3.
In the assessment performed 7 days after the administration, no pathological lesions were observed in the rabbits' eyes."

Other effects:

no other effects observed

Any other information on results incl. tables

Tabel of acute ocular irritation/damage scores in rabbits reconstructed from text information

Acute ocular irritation / damage score in rabbits

 

Rabbit no.	Part of the eye		Assessment after					Average assessments after 24, 48 and 72 h.
			1 h.	24 h.	48 h.	72 h.	7 days
1	Cornea		0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Lupus	2	1	1	1	0	1
		Oedema	1	1	0	0	0	0
2	Cornea		0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Lupus	2	2	1	1	0	1.3
		Oedema	1	1	1	0	0	0
3	Cornea		0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Lupus	2	2	1	1	0	1.3
		Oedema	1	1	1	0	0	0.7

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Slags, steelmaking, elec. furnace (carbon steel production – EAF C) and slags, steelmaking, elec. furnace (stainless/high alloy steel production – EAF S) (EAF C/EAF S) have no irritation potential on eye relevant for classification

Executive summary:

To test the eye irritation potential of slags, steelmaking, elec. furnace (carbon steel production – EAF C) and slags, steelmaking, elec. furnace (stainless/high alloy steel production – EAF S) (EAF C/EAF S),

tests were performed following OECD guideline 405. Fine-ground EAF C/EAF S was dosed, in its original form, at 0.1 g/animal into the conjunctival sac of one eye of each animal. After 1 h, the eyes of test animals were washed and eye reaction to the slag material was assessed after 1 h, 24 h, 48 h, 72 and 168 h after dosing. As no irritation was observed after 168 h, observation was terminated.

The slags, steelmaking, elec. furnace (carbon steel production – EAF C) and slags, steelmaking, elec. furnace (stainless/high alloy steel production – EAF S) (EAF C/EAF S), are neither irritating nor corrosive to the eye.