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Toxicological information

Eye irritation

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Administrative data

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).

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 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987-02-24
Deviations:
yes
Remarks:
,see "rational for reliability"
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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 alumina pink corundum
Test material form:
solid
Details on test material:
- Physical state: pink, solid
- Storage condition of test material: room temperature

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

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 eye irritant.