Manganese alumina pink corundum

Endpoint summary

Description of key information

Manganese alumina pink corundum has been tested in one in vivo skin irritation and one eye irritation study. All tests show a negative response, thus manganese alumina pink corundum  does not require classification either  as skin or as eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

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

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

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

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.

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.

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.

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.

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.

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.

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.

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:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Minor deviations with no effect on the results: - According to the guideline, both eyes should be examined regarding eye problems 24 hours before the test. It was not stated, if this was done in this study. - According to the guideline, after the substance has been placed in the conjunctival sac the eyelids are gently held together for about 1 second. This statement was missing in the report. -According to the guideline, a narrative description of the degree and nature of irritation or corrosion should be given, which is missing in this report. - Scoring according to modified Draize system (different wording).

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987-02-24

Deviations:

yes

Remarks:

,see "rational for reliability"

GLP compliance:

yes

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler; Offenbach/Main, FRG
- Weight at study initiation: mean weight of male: 2.76 kg; mean weight of females: 2.51 kg and 2.62 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

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 66 mg of the comminuted test substance) was applied in a single application to the conjunctival sac of the right eyelid. The untreated eye served as control.

Observation period (in vivo):

72 hours (Readings at 1 hour; 24 hours; 48 hours and 72 hours after application)

Number of animals or in vitro replicates:

one male/ two females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The substance was not washed out
SCORING SYSTEM: Scoring according to a modified Draize system
Chemosis (SW) and cornea (OP) (Opacity-degree of density):
0 = none
1 = slight
2 = well-defined
3 = severe
4 = very severe
Conjunctivae redness (RED):
0 = normal
1 = slight
2 = well-defined
3 = severe
Iris:
0 = normal
1 = circum-corneal injection
2 = iritis
Area of cornea invoolved (AR):
1 = > 0; < 1/4
2 = >= 1/4; < 1/2
3 = >= 1/2; < 3/4
4 = >= 3/4
Discharge (DI):
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

At the 1-hour observation slight conjunctivae redness was observed in all rabbits . Also, slightly increased discharge was seen in all animals.
These ocular effects were not seen anymore at the 24 hour observation.
No other ocular effects were observed.

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 eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

One study on skin irritation according to OECD TG 404 has been performed that indicated no erythema or oedema in any of the animals at the different readings.

One study on eye irritation according to OECD TG 405 has been performed. At the 1-hour observation slight conjunctivae redness was observed in all rabbits . Also, slightly increased discharge was seen in all animals. These ocular effects were not seen anymore at the 24 hour observation. No other ocular effects were observed.

Justification for classification or non-classification

Skin irritation

erythema, mean animal #1, 24 -72h after application: score=0

edema, mean animal #1, 24 -72h after application: score=0

erythema, mean animal #2, 24 -72h after application: score=0       

edema, mean animal #2, 24 -72h after application: score=0

erythema, mean animal #3, 24 -72h after application: score=0

edema, mean animal #3, 24 -72h after application: score=0

The classification criteria acc. to regulation (EC) 1272/2008 as irritating to skin are not met.

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

Eye irritation

conjunctivae score, mean animal #1, 24 -72h: score=0            

conjunctivae score, mean animal #2, 24 -72h: score=0            

conjunctivae score, mean animal #3, 24 -72h: score=0          

cornea score, mean animal #1, 24 -72h: score=0

cornea score, mean animal #2, 24 -72h: score=0

cornea score, mean animal #3, 24 -72h: score=0

iris score, mean animal #1, 24 -72h: score=0

iris score, mean animal #2, 24 -72h: score=0

iris score, mean animal #3, 24 -72h: score=0

chemosis score, mean animal #1, 24 -72h; score=0

chemosis score, mean animal #2, 24 -72h; score=0

chemosis score, mean animal #3, 24 -72h; score=0

The classification criteria acc. to regulation (EC) 1272/2008 as irritating to eyes are not met.

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

Respiratory irritation

The classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) for further information.