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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987-02-24
Deviations:
yes
Remarks:
: scoring according to modified Draize system (different wording); it was not stated, if the eyes were examined within 24 hours before testing starts; it was not stated, if the eyelids were held together after application of the test substance.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Sicocer F Eisenrosa 2320
- Physical state: solid, pink powder
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 2.60 kg and 3.07 kg; females: 2.78 kg
- Housing: 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; rabbits were housed singly
- Diet (about 130 g per animal per day): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (about 250 mL per animal per day): tap water
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS - animals were housed in fully air-conditioned rooms.
- 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): A single application of 0.1 mL bulk volume (about 118 mg of the comminuted test substance) was applied to the conjunctival sac of the right eyelid. The untreated eye served as control.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
2 males / 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the substance was not washed out.

SCORING SYSTEM: according to a modified Draize system

Chemosis and cornea (opacity-degree of density):
0 = none
1 = slight
2 = well-defined
3 = severe
4 = very severe

Conjunctivae redness:
0 = normal
1 = slight
2 = well-defined
3 = severe

Iris:
0 = normal
1 = circum-corneal injection
2 = iritis

Area of cornea involved:
1 = > 0; < 1/4
2 = >= 1/4; < 1/2
3 = >= 1/2; < 3/4
4 = >= 3/4

Discharge:
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased

OBSERVATIONS:
Weight determination: shortly before application of the test substance.
Symptoms were observed.

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:
Slight conjunctivae redness and slightly increased discharge were observed in all animals at the 1 hour observation.
Slight conjunctivae chemosis was observed in one animal at the 1 hour observation.
No ocular effects were observed during the 24, 48 and 72 hour observations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sicocer F Eisenrosa 2320 is not irritating to the eye.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.