Manganese alumina pink corundum

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Minor deviations from the guideline without an effect on the results: - According to the guideline, approx. 24 h before the test the fur should be removed by clipping or shaving. In this study it was stated that the fur was clipped at least 15 h before the beginning of the test. - According to the guideline, the examination for erythema and oedema should take place at 30 - 60 minutes, and then at 24, 48, 72 h after patch removal. In this study the examination took place at 30 -60 minutes after removal of the test patches and 24 h, 48 h, 72 h after the beginning of application. - A modified Draize scoring system was used. - The results of the reading at 30 - 60 minutes were missing in the test report. Instead a reading at 4 hours was mentioned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981-05-12

Deviations:

yes

Remarks:

, see "rational for reliability"

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Manganese alumina pink corundum

EC Number:

269-061-0

EC Name:

Manganese alumina pink corundum

Cas Number:

68186-99-2

Molecular formula:

Mn(x)Al(2-x)O3 0,01≤x≤0,25

IUPAC Name:

Manganese aluminium corundum

Test material form:

solid

Details on test material:

- Physical state: pink, solid
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler; Offenbach/Main, FRG
- Weight at study initiation: mean weight rabbit #1 2.62 kg; mean weight rabbits #2 2.68 kg; mean weight rabbit #3 2.87 kg
- Housing: Individual housing of rabbits; Cage made of stainless steel with wire mesh walk floors; Floor area: 40 cm X 51 cm; No bedding in the cages; Sawdust in the waste trays
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG; CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test patch (2.5 cm X 2.5 cm) was covered with a dose of 0.5 g of the unchanged test substance and has been moistened with aqua. bidest.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours (Readings at 30 -60 minutes after removal of the test patches and 24 hours, 48 hours, 72 hours after the beginning of application)

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Application area was 2.5 cm X 2.5 cm. The application site was the upper third of the back or flanks. The untreated skin sites of the animals served as negative control.
- Type of wrap if used: Test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: At the end of the exposure period

SCORING SYSTEM: A modified Draize scoring system was used.
Evaluation of erythema and oedema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.

Irritant / corrosive response data:

No erythema or oedema was observed in any of the animals at the different readings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.