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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
- Principle of test: A single application of 0.1 g of the test item suspended in peanut oil DAB 7 or 0.1 mL of peanut oil DAB 7 was instilled into the conjunctival sac of the left eye of male New Zealand White-EMD rabbits. The right eye remained untreated and served as the control. Animals were observed for one week.
- Short description of test conditions: Experimental conditions were maintained at 23 to 33 °C with 45 to 73 % relative humidity.
- Parameters analysed / observed: Eye lesions
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
EMD
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.6 to 3.2 kg (mean 2.9 kg)
- Housing: Individually caged in standard cages on wire grids.
- Diet: Altromin MS, ad libitum.
- Water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 33 °C
- Humidity (%): 45 to 73 %

Test system

Vehicle:
other: peanut oil DAB 7
Controls:
yes, concurrent no treatment
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g test item suspended in vehicle

VEHICLE
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
The eyes of the rabbits were examined daily (Monday through Saturday) for one week.
Number of animals or in vitro replicates:
3 male rabbits per treatment and vehicle control
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize, FDA-Appraisal (1959)

TOOL USED TO ASSESS SCORE: Hand lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
not measured/tested
Irritant / corrosive response data:
A single application of the test item or vehicle was tolerated by the rabbits without irritation and reaction. The treated eye did not differ from the untreated control eye.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No symptoms of eye irritation occurred within 7 days.
Executive summary:

Eye irritation of the test item was tested in male New Zealand White-EMD rabbits. A single application of 0.1 g of the test item suspended in peanut oil DAB 7 or 0.1 mL of peanut oil DAB 7 was instilled into the conjunctival sac of the left eye. The right eye remained untreated and served as the control. Animals were examined daily for eye lesions for one week and changes were evaluated according to Draize, FDA-Appraisal (1959). No symptoms of eye irritation occurred within 7 days in animals treated with test item or vehicle. The treated eye did not differ from the untreated control eye. This study is considered to be reliable with restriction (Klimisch 2) as it was conducted similar to OECD Guideline 405, however there were minor limitations in experimental design and reporting.