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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Resultsopen allclose all
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
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
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, the following were observed in the conjunctive of the three rabbits' eyes: conjunctival lupus manifested as crimson, diffuse redness (individual vessels poorly distinguishable), pericorneal injection, third eyelid congestion, slight conjunctival oedema and secretion on eyelids and eyelid secretion.
In the assessment performed 24 hours after exposure, the lupus of the conjunctiva in rabbit no. 1 has been reduced - conjunctival injection was observed. In addition, pericorneal injection, third eyelid congestion and oedema were observed in the conjunctiva of rabbit no. 1. In rabbits 2 and 3 diffuse crimson redness (individual vessels poorly distinguishable), pericorneal injection and third eyelid congestion were observed. In addition, third eyelid oedema and secretion on eyelids and eyelid hair was observed.
In the assessment performed 48 hours after exposure, conjunctival injection and third eyelid congestion were observed in rabbit 1. In rabbits 2 and 3 conjunctival injection, pericorneal injection and third eyelid congestion were observed. In addition, third eyelid oedema and small quantities of secretion were observed in rabbits 2 and 3.
In the assessment performed 72 hours after exposure, conjunctival injection and third eyelid congestion were observed in the three rabbits. In addition, 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

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, converter (BOS) and slags, steelmaking (SMS) (BOS/SMS) have no irritation potential on eye relevant for classification
Executive summary:

To test the eye irritation potential of slags, steelmaking, converter (BOS) and slags, steelmaking (SMS) (BOS/SMS),

tests were performed following OECD guideline 405. Fine-ground BOS/SMS 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, converter and slags, steelmaking (BOS/SMS), are neither irritating nor corrosive to the eye.