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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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was only carried out for 7 days and the effects are not fuly reversibel within that time period but the a decrease in severty was seen over a period of 7 days. Therefore the assumption is made that the effests are likely to be fully reversible within 21-days and the study may be used for C&L.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
audited inhouse

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Appereance: fine, white powder.
Name: Elfan AT 84

No further details

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm D -2740 Bremervorde, Neuendamm 88
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Single caging in battery of cages size: 40 cm high, 45 cm wide, 50 cm long with paper roll disposal system.
- Diet (e.g. ad libitum): ad libitum
Producer: Ssniff Spezialfutter GmbH, 4770 Soest/ Westfalen, Name: Ssniff Mu Z (Alleindiat fur Zuchtkaninchen) Type: pellets, 1.0 - 1.5 cm large, 0.5 cm diameter
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50-85
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
0.1 g of the testmaterial was placed into the conjunctival sac of the left eye while the right eye served as I control. On animal 4- 6 the treated eye was carefully washed out 4 sec p.a. with lukewarm water.
Observation period (in vivo):
Prior to treatment, 24 hours p. a. and if necessary 7 days p. a., the eyes were examined for potential eyelesions by means of 1 % Fluorescin. The eyes were scored at 1, 2, 8 hours and 1, 2, 3, 4, 5, 6 and 7 days after treatment.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): On animal 4- 6 the treated eye was carefully washed out
- Time after start of exposure: 4 sec p.a. with lukewarm water


SCORING SYSTEM: DRAIZE
Scoring system eye irritation

Cornea: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Nacrous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity

Area of Cornea Involved
1 One quarter (or less) but not zero
2 Greater than one quarter but less than half
3 Greater than half but less than three quarters
4 Greater than three quarters, up to whole area

Iris
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) Iris still reaction to light (sluggish reaction is positive)
a x 5, total maximum = 10 No reaction to light .Hemorrhage. Gross destruction (any or all of these) (2)

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)

0 Blood vessels normal
1 Some blood vessels definitely hyperaemic
(injected)
2 Diffuse, crimson colour, individual vessels not easily discernible
3 Diffuse, beefy red

Chemosis (lids and/or nictitating membranes)
0 No swelling 0
1 Any swelling above normal (includes nictitating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed

Discharge
0 No discharge
1 Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 Discharge with moistening of the lids and hairs just adjacent to lids
3 Discharge with moistening of the lids and hairs a considerable area around the eye
Score (a + b + c ) x 2 Total maximum = 20

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animals 1-3
Time point:
other: 24-48-72 hours
Score:
1.2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: The study was terminated after 7 days.
Irritant / corrosive response data:
After treatment in none of the animals effects on the cornea were observed. One hour after treatment effects on the Iris were observed in all animals. One animal from the group where the eye was not washed out did not react to light up to 5 days after treatment. In two animals from this group effects on the Iris were not fully reversible, in one animal the effests disappeared after 5 days. In the group where the eyes were washed out after 4 seconds effects were not fully reversible in one animals and in the two other animals effects were gone on day 2 or 4. Conjunctivae were affected in all animals with 4 as the highest score in one animal for chemosis. In the first group on day 2 effects started to decrease but were only fully reversible within 7 days in one animal. In the second group the same effecst were observed but only less severe with a higest score of 3. In two animals effects were fully reversible on day 4 or 5, in the third animals effects were not fully reversible after 7 days.

Any other information on results incl. tables

Without removal of the test substance

Rabbit No and sex

Region of the eye

Hours after instillation

Average 24-48-72hours

24

48

72

1

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

2

2

2

2

Conjunctivae

Redness

3

3

2

2.7

Chemosis

3

3

2

2.7

Discharge

2

2

1

1.7

2

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

1

1

1

Conjunctivae

Redness

3

1

1

1.7

Chemosis

3

2

1

2

Discharge

2

1

1

1.7

3

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

1

1

1

Conjunctivae

Redness

3

1

1

1.7

Chemosis

4

2

2

2.7

Discharge

2

2

1

1.7

Removal of the test substance after 4 seconds

Rabbit No and sex

Region of the eye

Hours after instillation

Average 24-48-72hours

24

48

72

4

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

1

1

1

Conjunctivae

Redness

3

3

3

3

Chemosis

3

3

2

2.7

Discharge

2

2

2

2

5

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

1

1

1

Conjunctivae

Redness

3

1

1

1.3

Chemosis

3

2

1

2

Discharge

2

0

0

0.7

6

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

0

0

0.3

Conjunctivae

Redness

3

2

2

2.3

Chemosis

3

2

2

2.3

Discharge

2

0

0

0.7

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test substance causes a score of ≥ 1 for iris and a ≥ 2 score for chemosis. The effects are not fully reversible within 7 days but the a decrease in severty was seen over a period of 7 days. Therefore the assumption is made that the effests are likely to be fully reversible within 21-days and the substance is calssified in catergory 2A (irritating to eyes).
Executive summary:

An eye irritation study was carried out acoording to OECD405 and inhouse quality assurance was in place.

0.1g of the test substance (white powder) was instilled in the eyes of 6 rabbits. In 3 rabbits the eyes were washed after 4 seconds. Prior to treatment, 24 hours post application and if necessary 7 days post application, the eyes were examined for potential eyelesions by means of 1 % Fluorescin.

The eyes were scored at 1, 2, 8 hours and 1, 2, 3, 4, 5, 6 and 7 days after treatment.

After treatment in none of the animals effects on the cornea were observed. One hour after treatment effects on the Iris were observed in all animals. One animal from the group with unwashed eyse did not react to light up to 5 days after treatment. In two animals from this group effects on the Iris were not fully reversible, in one animal the effests disappeared after 5 days.

In the group where the eyes were washed out after 4 seconds effects were not fully reversible in one animals and in the two other animals effects were gone on day 2 or 4. Conjunctivae were affected in all animals with 4 as the highest score in one animal for chemosis.

In the first group on day 2 effects started to decrease but were only fully reversible within 7 days in one animal.

In the second group the same effecst were observed but only less severe with a higest score of 3. In two animals effects were fully reversible on day 4 or 5, in the third animals effects were not fully reversible after 7 days.

The test substance causes a score of ≥ 1 for iris and a ≥ 2 score for chemosis. The effects are not fully reversible within 7 days but the a decrease in severty was seen over a period of 7 days. Therefore the assumption is made that the effests are likely to be fully reversible within 21-days and the substance is classified in catergory 2A (irritating to eyes).