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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
Study period:
1987-04-28, 1987-05-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Organic
- Physical state: Solid
- Purity: Lab. sample
- Lot/batch No.: WR 629
- Expiration date of the lot/batch: 1990-12
- Storage condition of test material: Room temperature, in the dark
- Other: Insoluble in water

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks
- Weight at study initiation: 2190 - 2420 g
- Housing: Individually in metal cages
- Diet: Ad libitum, standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: Ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as control.
Amount / concentration applied:
0.1 mL of undiluted test material (corresponding to 38 mg) was applied.
Duration of treatment / exposure:
72 h; The treated eye was not rinsed.
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
3
Details on study design:
The irritant/corrosive potency was scorred according to the EEC commission directive No. 83/467, 1983. For further details see additional information.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Corneal opacity graded 1 was observed 1 h after application.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Corneal opacity graded 1 was observed 1 h after application.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Iritis graded 1 was observed 1h after application.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Redness of conjunctiva graded 1 was observed 1 h after application.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Conjunctival redness graded 2 was observed 1 h after application.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Chemosis graded 1-2 was observed 1 h after application.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Chemosis graded 1-2 was observed 1 h after application.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Chemosis graded 1-2 was observed 1 h after application.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material invoked no meaningful indications of irritation over the duration of the test. The test material is not considered an eye irritant.
Executive summary:

In this guideline (OECD 405) study conducted to GLP standards, the test material (EC 404-360-3) was determined to be not irritating to eyes. Undiluted test material (0.1 ml, corresponding to 38 mg) was applied directly to an eye of three rabbits with the other eye of each being the control. The conditions of the eyes were then observed at 1, 24, 48 and 72 hours. At 1 hour, only slight effects graded 1 or 2 were observed. After 24 hours conjunctival redness graded 1 was observed in one animal only, this was fully reversible over the duration of the test. Thus, according to CLP regulation 1272/2008, this substance is not classified for eye irritation.