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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:
06. Oct 1965 - 14. Oct 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Principles of method if other than guideline:
BASF-Test: 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Analytical purity: 98 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 50µl
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: 72 h reading is missing
Irritant / corrosive response data:
The detailed findings of the study are given in table 1 as converted gradings from BASF internal into OECD Draize system gradings.

Any other information on results incl. tables

Table 1: Findings of two animals: animal 1/animal 2

 Time      Opacity Iritis Erythema Chemosis                   
 1 h    2/2 0/0 1/1  0/0                  
 24 h    3/3  2/0  3/3  0/0                  
 48 h    3/3  2/0  3/3 0/0                   
 72 h    -/-  -/-  -/-  -/-                  
 8 d    3/3  2/0  3/3  0/0                  

The original readings at 72 h are missing. The original BASF grading was converted into the numerical grading according the OECD Draize system.

Mean values over 24 h and 48 h; The 72 h reading is missing:

Animal1: Opacity: 3; Iritis: 2; Erythema: 3;

Animal2: Opacity: 3; Iritis: 0; Erythema: 3;

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The application of the test substance caused corrosion to the exposed eyes predominantly expressed by severe corneal opacity, severe erythema and iritis. After 48 h crusty eyelids, suppuration and staphyloma were noted. Severe corneal opacity and staphyloma are considered to be irreversible effects to ophthalmic tissue.