Aluminium potassium bis(sulphate)

Endpoint summary

Description of key information

The results of the key study on skin irritation of aluminium sulfate as read across substance of aluminium
potassium bis sulphate from Lansdown and the report of ATSDR showed that aluminium sulfate as one of the two 
inorganic dissociation components of aluminium potassium bis sulphate is not classified as skin irritating according to EU regulation 1272/2008 and
EU regulation 286/2011 (2. ATP). For potassium sulfate, the second inorganic read across component of aluminium 
potassium bis sulphate, there is no information known about irritation/corrosion effects.
The key eye irritation study from Tiwari et al. of aluminium ammonium sulfate as read across 
substance of aluminium potassium bis sulphate showed that ammonium alum is not 
eye irritating according to EU regulations 1272/2008 and 286/2011. Because the chemical properties of ammonium alum and 
potassium alum are comparable, aluminium potassium bis sulphate is not classified as 
eye irritating/eye corrosive according to EU regulations 1272/2008 and 286/2011 (2. ATP).
 
Based on this information aluminium potassium bis sulphate is not classified as 
irritating/corrosive according to EU regulations 2372/2008 and 286/2011 (2. ATP).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: no OECD guideline, but well documented

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

not specified

GLP compliance:

not specified

Species:

mouse

Strain:

other: Carworth TF1

Details on test animals or test system and environmental conditions:

female TF1 Carworth mice

Type of coverage:

not specified

Preparation of test site:

not specified

Duration of treatment / exposure:

5d/1x/d

Irritation parameter:

overall irritation score

Basis:

other: hyperplasia, micro abscess formation, dermal inflammatory cell infiltration, and occasional ulceration

Remarks on result:

other: no skin damage effects

NOAEL-5d/1x/d: 10%, no skin damage effects

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

NOAEL-5d/1x/d: 10 % (w/v), not irritating, no skin damage.Calculated for AlK(SO4)2: 13.25 % (w/v)Therefore the substance is not classified as skin irritating according EU-Regulation No. 1272/2008 (CLP)and EU regulation 286/2011 (2. ATP).

Executive summary:

NOAEL-5d/1x/d: 10%, not irritating, no skin damage.

Calculated for AlK(SO4)2: 13.25 % (w/v)

Therefore the substance is not classified as skin irritating according EU-Regulation 1272/2008 (CLP)

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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)

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.

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

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the results of the key studies of skin and eye irritation with aluminium sulfate and aluminium ammonium sulfate as

read across substances of aluminium potassium bis sulphate, the substance aluminium potassium bis sulphate is not

classified as skin irritating and eye irritating/eye corrosive according to EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP).

Justification for selection of skin irritation / corrosion endpoint:
Based on the results of the key study no skin irritation was established under the test conditions.
Therefore Aluminium potassium bis sulphate is not classified as skin irritating according EU regulation
1272/2008 and EU regulation 286/2011 (2. ATP) under the test conditions.

Justification for selection of eye irritation endpoint:
Based on the results of the key study no eye irritating/corrosion was established
under the test conditions.
Therefore Aluminium potassium bis sulphate is not classified as eye irritating/eye corrosion according EU regulation
1272/2008 and EU regulation 286/2011 (2. ATP) under the test conditions.

Justification for classification or non-classification

Based on the results of the studies on the endpoints "skin irritation" and "eye irritation/corrosion"

the substance is determined as "not skin irritating" and "not eye irritating/no eye corrosion".

Therefore Aluminium potassium bis sulphate is not classified as "skin irritating" and "eye irritating/ eye corrosive" for these endpoints according EU regulation EU 1272/2008 and EU regulation 286/2011 (2. ATP).