Aluminum chloride, basic

Eye irritation

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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.