Aluminium potassium bis(sulphate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

14th December 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed accordingly to OECD guideline No. 405 and in compliance with GLP.Moreover, the information on the test substance is available.

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:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium ammonium bis(sulphate)

EC Number:

232-055-3

EC Name:

Aluminium ammonium bis(sulphate)

Cas Number:

7784-25-0

Molecular formula:

Al.H3N.2H2O4S

IUPAC Name:

aluminium ammonium bis(sulphate)

Details on test material:

Name of test material (as cited in study report): Curb Powder, Aluminium ammonium sulfate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test animals:Source: Breeding facility, Jai Research Foundation, IndiaAge at study initiation: No dataWeight at study initiation: 2.57 - 2.67 kgFasting period before study: No dataHousing: individual, in stainless steel wire cages, 45.7 cm breadth x 60.9 cm length x 45.7 cm heightDiet (e.g. ad libitum): ad libitum; rabbit pellet diet (Amrut brand) manufactured by Pranav Agro Industries Ltd., Pune, Mahashtra. IndiaWater (e.g. ad libitum): ad libitum in a polypropylene water bottle with a stainless steel nozzle. The drinking water was filtered through Aquagard water filter systemAcclimation period: 6 daysEnvironmental conditions:Temperature (°C): 20 to 22 °CHumidity (%): 65 %Air changes (per hr): 17 air changes per hourPhotoperiod (hrs dark/hrs light): 12 h artificial light/ 12 h darkness

Test system

Vehicle:

water

Controls:

other: Both control and treated eyes for each animal

Amount / concentration applied:

Test material:Amount(s) applied (volume or weight with unit): 100 mg of Aluminium ammonium sulfateConcentration (if solution): no dataVehicle:no data

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

Three adult males

Details on study design:

Removal of the test substance:Washing (if done): both eyes (control and treated) of all rabbits were washed with distilled waterTime after start of exposure: 24 h after instillation of the test substanceScoring system:The irritant response was scored following the method provided by the guidelines of the OECD No. 405Tool to assess score:fluorescein; the eyes of each animal were examined using fluorescein dye staining (Swinyard, 1990)

Results and discussion

In vivo

Results

Irritation parameter:

other: Mean individual scores

Time point:

24/48/72 h

Remarks on result:

other: see table below

Irritant / corrosive response data:

The mean individual scores were presented in the Table 7.3.2.1 (below)

Other effects:

At 1 h after treatment, slight redness (some blood vessels definitely hyperaemic) was observed in treated eyes of two rabbitsand diffused crimson colour with individual blood vessels not easily discernible was observed in one rabbit.At 24 h after treatment; chemosis (swelling above normal) and redness (diffused crimson colour with individual blood vesselsnot easily discernible) was observed in treated eye of all rabbits. Examination with fluorescein dye and cobalt blue filter(corneal damage showing as green fluorescein) revealed damage to 1/4 corneal epithelium of the treated eye of two rabbits.At 48 h after treatment, redness (some blood vessels definitely hyperaemic) and chemosis (swelling above normal) was observedin treated eye of two rabbits.At 72 h after treatment, treated eyes of all rabbits appeared normal.No abnormalities were detected in the control eye of the rabbits during the course of the study. No damage to corneal epithelium was observed during the examination with fluorescein dye and cobalt blue filter.No clinical signs related to treatment other than eye irritations were observed in any of the three rabbits.

Any other information on results incl. tables

Rabbit No.           Mean individual scores at 24, 48 and 72 hours    Corneal opacity  Iris lesion Conjunctivae redness   Conjunctivae chemosis  1  0  0  1  0.67  2  0  0  1  0.67  3  0  0  0.67  0.33

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Rabbit-24h: not irritating.As Aluminium ammonium bis sulphate is not irritating and comparable with Aluminium potassium bis sulphate.Therefore Aluminium potassium bis sulphate is not classified as eye irritating according to EU Regulation 1272/2008and EU regulation 286/2011 (2. ATP).

Executive summary:

In an eye irritation study, aluminium ammonium sulfate as powder was applied by instillation (0.1 g) in eyes to

3 adult males New Zealand white rabbits. The study was performed in compliance with Good Laboratory Practices

and according to OECD guideline 405 (Acute Eye Irritation) and EC.B.5.

After treatment with Aluminium ammonium sulfate, the eyes of all animals were observed for signs of ocular

irritation at 1, 24, 48 and 72 hours. For each observation, scoring for ocular lesions was undertaken for the

cornea, the iris and the conjunctiva.

At 1 h after treatment, slight redness (some blood vessels definitely hyperaemic) was observed in treated eyes of two rabbits and diffused crimson colour with individual blood vessels not easily discernible was observed in one rabbit.

At 24 h after treatment; chemosis (swelling above normal) and redness (diffused crimson colour with individual blood vessels not easily discernible) was observed in treated eye of all rabbits. Examination with fluorescein dye and cobalt blue filter (corneal damage showing as green fluorescein) revealed damage to 1/4 corneal epithelium of the treated eye of two rabbits.

At 48 h after treatment, redness (some blood vessels definitely hyperaemic) and chemosis (swelling above normal) was observed in treated eye of two rabbits.

At 72 h after treatment, treated eyes of all rabbits appeared normal.

No abnormalities were detected in the control eye of the rabbits during the course of the study.

No damage to corneal epithelium was observed during the examination with fluorescein dye and cobalt blue filter.

No clinical signs related to treatment other than eye irritations were observed in any of the three rabbits.

No corneal and iridal lesion was observed (mean individual score 0.0).The mean individual scores

for the conjunctivae were 1.0 - 1.0 - 0.67 for the redness and 0.67 - 0.67 - 0.33 for the chemosis.

Under the test conditions Aluminium ammonium bis sulphate is not classified as eye irritating and as read across substance

comparable with Aluminium potassium bis sulphate.

Therefore Aluminium potassium bis sulphate is not classified as eye irritating according to EU Regulation 1272/2008

and EU regulation 286/2011 (2. ATP).