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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:
April 1996 - May 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Information on substance identity and composition is lacking. Batch No. is given, guideline 405 is followed and study is performed according to GLP.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: age of animals is not mentioned
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Aqualenc E
- Physical state: yellow liquid
- Analytical purity: no CoA
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: Composition does not add up to 100%: Al2O3 = 17.00%
- Lot/batch No.: TDE-95-299, received November 14, 1995
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other:
Alkalinity (OH/(3*Al)) = 37.1%
pH = 0.4
Density = 1.35-1.39 g/cm3 at 20°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, France
- Age at study initiation: no data
- Weight at study initiation: on the day of treatment 2.3 ± 0.1 kg
- Housing: Individual housing
- Diet (e.g. ad libitum): free access to pelleted diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: From: April 25, 1996 To: May 16, 1996

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml into the left eye
- Concentration (if solution): test article was used in its original form


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
single application into the left eye (the lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye served as control). The eyes were not rinsed
Observation period (in vivo):
- approximately 1 hour and 24, 48 and 72 hours after administration
- when there is persistent ocular irritation after 72 hours the observation period is extended to a maximum of 21 days (until day 22)
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not rinsed
- Time after start of exposure: not applicable


SCORING SYSTEM: see below (Table 7.3.2/1)


TOOL USED TO ASSESS SCORE:
- Cornea: 2 drops of 0.5% sodium fluorescein solution; direct examination or, if necessary, with an Ultra-Violet lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 21 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
No ocular corrosion mentioned.
Other effects:
- One animal was killed on day 12. This animal showed also white spots on the conjunctivae, alopecia around the eye and neovascularisation.
- The two other animals also showed alopecia and neovascularisation.

Any other information on results incl. tables

Table 7.3.2/2: Summary of ocular lesions:

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2/3

Mean score iritis

Days 1/2/3

 

Mean score redness Days 1/2/3

Mean score chemosis Days 1/2/3

1

1

2

3

7

14

21

01

Cornea

Iris

Redness

Chemosis

0

0

0

2

1

1

3

3

1

1

3

2

1

1

3

2

1

1

3

1

1

1

2

1

1

0

0

0

1

 

1

 

 

3

 

 

 

2.33

02

Cornea

Iris

Redness

Chemosis

0

0

0

2

1

1

2

3

2

1

2

3

2

1

2

3

3

1

2

3

-

-

-

-

-

-

-

-

1.67

 

1

 

 

2

 

 

 

3

03

Cornea

Iris

Redness

Chemosis

0

0

0

2

2

0

3

3

2

1

3

2

1

1

3

2

1

1

3

2

0

0

0

1

/

/

/

/

1.67

 

0.67

 

 

3

 

 

 

2.33

Mean all anim.

 

 

 

 

 

 

 

 

 

 

1.45

 

0.89

 

2.67

 

2.55

- Animal killed

/ Ocular examination not performed on day 21, because effects were gone on day 19

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the test conditions of this study, it was concluded that the test compound, Aqualenc E, induced a severe eye irritation. The eye effects weren’t completely reversible within 21 days. Furthermore, one animal was killed due to severe eye effects. Therefore, the product is classified in Category 1 (H318: causes serious eye damage) according to the CLP Regulation (1272/2008) and the GHS.
Executive summary:

In an eye irritation study performed according to OECD test guideline No. 405 and in compliance with GLP, 0.1 ml of Aqualenc E (17% Al2O3) was instilled into the conjunctival sac of one eye of three New Zealand white rabbits. The other eye of each rabbit served as control. Eyes were examined at 1, 24, 48 and 72 hours and 21 days following treatment and grading according to Draize scale.

Individual mean scores at 24, 48 and 72 h after exposure were 1, 1.67, 1.67 for corneal lesions, 1, 1, 0.67 for Iris lesions, 3, 2, 3 for conjunctival redness and 2.33, 3, 2.33 for chemosis respectively. The eye effects weren’t completely reversible within 21 days. Furthermore, one animal was killed due to severe eye effects. Therefore, the product causes irreversible effects on the eye.

Under the test conditions, Aluminium hydroxide chloride, low basicity is classified in Category 1 according to the CLP Regulation (1272/2008) and the GHS.