Aluminium ammonium bis(sulphate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

In vivo skin irritation study available

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2002-09-18 to 2002-12-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed accordingly to the OECD Guideline No. 404 and in compliance with the 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 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Not applicable

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding Facility, Jai Research Foundation, India
- Age at study initiation: no data
- Weight at study initiation: 2.77 to 2.86 kg
- Fasting period before study: No data
- Housing: individual, in stainless steel wire cages. 45.7 cm breadth x 60.9 cm lenght x 45.7 cm height.
- Diet (e.g. ad libitum): ad libitum; rabbit pellet diet (Amrut brand) manufactured by Pranav Agro Industries Limited, Pune, Mahashtra, India
- Water (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 system.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22 °C
- Humidity (%): 65%
- Air changes (per hr): 17 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h artificial light / 12 h darkness

IN-LIFE DATES: From 2002-10-26 to 2002-11-15

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

water

Remarks:

distilled

Controls:

other: control sites

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of Aluminium ammonium sulfate moistened in distilled water
- Concentration (if solution): no data

VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Lot/batch no. (if required): not required
- Purity: no data

Duration of treatment / exposure:

Four-hour exposure period

Observation period:

Following the four-hour exposure period, the skin of each rabbit was observed at 1, 24, 48 and 72 hours after the patches were removed.

Number of animals:

Three males

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage: no data
- Type of wrap if used: gauze patch, secured at the margins by Medi tape 330 hypo-allergic surgical tape (manufactured by JMS Co. Ltd., Hiroshima 730, Japan).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period, the residual test substance was removed with cotton soaked in distilled water.
- Time after start of exposure: four hours

SCORING SYSTEM: Draize Method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Very slight erythema was observed on the treated site of all the rabbits at 1h after the patch removal.
Treated skin sites of all the rabbits appeared normal at 24, 48 and 72 hours. Control skin sites of all the rabbits appeared normal throughout the experimental period.
The acute dermal irritation index for Aluminium ammonium sulfate calculated was 0.

Other effects:

No clinical signs related to treatment, other than dermal irritation, was observed in any of the rabbits during the experimental period.

Any other information on results incl. tables

Table 7.3.1/1: Mean of Dermal Irritation Scores for ECC Classification

Animal N°	Mean of Scores at 24, 48 and 72 hours
	Erythema	Oedema
1	0	0
2	0	0
3	0	0

Table 7.3.1/2: Clinical observations and Body Weight registration

                                                    

Animal N°	Observations made on day				Body Weight (kg) before treatment	Body Weight (kg) at the end of the Study
	#	1	2	3
1	1	1	1	1	2.86	2.85
2	1	1	1	1	2.77	2.69
3	1	1	1	1	2.86	2.55

# : application day

1 : normal

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Aluminium ammonium sulfate is not classified as irritant to skin according to the criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.

Executive summary:

In an acute skin irritation study, aluminium ammonium sulfate was applied by dermal way to 3 adult males New Zealand white rabbits.This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 404 (Acute Dermal Irritation) and EC B.4.

Aluminium ammonium sulfate powder (0.5 g) was moistened with distilled water and applied on a clipped site of 6 cm² of the dorso-lumbar region of each rabbit. The application site was covered with a gauze patch and hypo-allergic surgical tape. After a four-hour exposure period, the residual test substance was removed.

Skin reactions were observed at 1, 24, 48 and 72h after the patch removal. The site of application was visually assessed and scored as per the Draize method.

Very slight erythema was observed on the treated site of all the rabbits at 1h after the patch removal. Treated skin sites of all the rabbits appeared normal at 24, 48 and 72 hours. Control skin sites of all the rabbits appeared normal throughout the experimental period.

No clinical signs related to treatment, other than dermal irritation, was observed in any of the rabbits during the experimental period.

The mean individual scores for erythema and edema were 0.0-0.0-0.0.

Under the test conditions, aluminium ammonium sulfate is not classified as skin irritant according to the criteria of the Annex VI to the Regulation N°1272/2008 and to the 67/548/EEC Directive.

This study is considered as acceptable and satisfies the requirement for the irritation study endpoint.