Aluminium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 5 to 29 March 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP guideline study well conducted.

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:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 005

Cas Number:

16828-12-9

Molecular formula:

Al2 (SO4)3, 14 H2O

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): ALUM - 17
- Physical state: white powder
- Storage condition of test material: room temperature
- Receiving date: 19 January 1990

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: twelve to sixteen weeks old.
- Weight at study initiation: 2.73 Kg.
- Housing: suspended metal cage.
- Diet (e.g. ad libitum): Rabbit diet, Preston Farmers Limited.
- Water (e.g. ad libitum): drinking water.
- Acclimation period: five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 59-63%
- Air changes (per hr): 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light.

IN-LIFE DATES: no data.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

single application (the eyelids were gently held together for one second). The other eye, remaining untreated, serves as a control.

Observation period (in vivo):

1, 24 and 48 hours following treatment.

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
- Time after start of exposure: not applicable.

SCORING SYSTEM: Draize scale.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

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:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

The animal was sacrificed for humane reasons following the 48 hour period of observation. Sloughing of the cornea was observed both at 24 and 48 hours.

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:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

The animal was sacrificed for humane reasons following the 48 hour period of observation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

The animal was sacrificed for humane reasons following the 48 hour period of observation. White appearance of the nictitating membrane was observed both at 24 and 48 hours. Sloughing of the nictitating and conjunctival membranes were observed at 48 hours.

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

The animal was sacrificed for humane reasons following the 48 hour period of observation

Irritant / corrosive response data:

- A dulling of the normal lustre of the corneal surface was noted one hour after treatment. Diffuse corneal opacity was noted at the 24 and 48-hour observations.
- Iridial inflammation was noted one hour after treatment and at the 24 and 48-hour observations;
- Moderate conjunctival irritation was noted one hour after treatment and at the 24 and 48-hour observations.
- Other adverse ocular effects noted were sloughing of the cornea at the 24 and 48 - hour observations, pale appearance of the nictitating membrane one hour after treatment, white appearance of the nictitating membrane at the 24 and 48- hour observations and sloughing of the nictitating and conjunctival membranes at the 48-hour observation. The animal was killed for humane reasons following the 48-hour observation.

Other effects:

None.

Any other information on results incl. tables

Table 7.3.2/1: Mean irritant/corrosive response data of one treated animal at each observation time up to removal from the test:

Anim. No.	Effect	Hours	Days after application			Mean score cornea Days 1/2	Mean score iritis Days 1/2	Mean score redness Days 1/2/3	Mean score chemosis Days 1/2/3
		1	1	2
80 Female	Cornea     Iris   Redness     Chemosis	4 (d)     1   2 (Pa)     3	2 (sl)   1   2 (W)   3	2 (sl)   1   2 (SL W) 3		2	1	2	3

D : dulling of the normal lustre of the corneal surface

Sl : sloughing of the cornea

Pa : pale appearance of the nictitating membrane

W : white appearance of the nictitating membrane

SL : sloughing of the nictitating and conjunctival membranes

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, the test substance causes serious damage to eyes as corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed. Therefore, ALUM-17 (17% Al2O3) was classified in category 1 for eye damage according to Regulation (EC) N° 1272 -2008 (CLP) and to GHS.

Executive summary:

In an eye irritation study performed similarly to the OECD test guideline No. 405 and according to GLP compliance, 0.1 g of ALUM-17 as powder was instilled into the conjunctival sac of one eye of only one female New Zealand rabbit. The other eye remained untreated served as control. Eyes were examined at 1, 24 and 48 hours following treatment and grading according to Draize scale.

A dulling of the normal lustre of the corneal surface was noted one hour after treatment following to a diffuse corneal opacity noted at 24 and 48-hours observations. Iridial inflammation and moderate conjunctival irritation were observed at 1, 24 and 48-hours observations. Other adverse effects included sloughing of the cornea up to 48 hours, pale appearance of the nictitating membrane one hour after treatment followed by white appearance of the nictitating membrane at 24 and 48-hour observations and sloughing of the nictitating and conjunctival membranes at 48-hours observation.The animal was sacrificed for humane reasons following the 48 hour period of observation.

Under the test conditions of this study, corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed and considered as serious ocular effects. Therefore, ALUM-17 was classified in category 1 for eye damage according to Regulation (EC) N° 1272 -2008 (CLP) and to GHS.