Aluminum chloride, basic

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 January 1986 - 24 January 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study was performed according to OECD guideline 404 and under GLP conditions.

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:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Directive 84/449/EEC

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Remarks:

Statement of Compliance

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Povimal
- Physical state: Light gels, almost clear solution
- Analytical purity: 35%
- Storage condition of test material: At 22 °C in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 3.1 - 3.4 kg
- Housing: Individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 ml
- Concentration (if solution): 100 % (undiluted)

Duration of treatment / exposure:

4 hours

Observation period:

30 and 60 min, and 24, 48 and 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Approx. 24 hours prior to the start of the experiment 3 rabbits were depilated in the dorsal region of the trunk with an electric hair clipper on an area of approx. 25 cm2. Only animals with intact skin were used. Each animal was fixed on the prepared skin site with a wound plaster with 2.5 x 2.5 cm. The area was covered with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): remaining test substance removed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: subjective numerical according to OECD Guideline 404 (Erythema and Eschar formation / Oedema formation). Maximum possible score: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

Mean Individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Mean Individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

Mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritant/corrosive response

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions of this study, the test material Povimal was found to be non-irritant to the rabbit skin. Therefore, no classification is required according to the Regulation (EC) N° 1272/2008 (CLP) and the GHS.

Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand White rabbits were dermally exposed to 0.5 ml of Aluminiumhydroxichloride (undiluted) under a semi-occlusive dressing for 4 h. After removal of the residual test item, skin irritation was scored by the method of Draize at 24, 48 and 72 h after exposure.

 

No skin responses were noted during the study. All treated skin sites appeared normal at the 24 h observation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for erythema and 0, 0, 0 for oedema score, respectively. In this study, Povimal is therefore not a skin irritant on rabbits.

 

Under the test conditions, Aluminiumhydroxichloride is not classified as irritating to skin according to the Regulation (EC) N° 1272/2008 (CLP) and the GHS.