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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:
15 Jun 1965 - 23 Jun 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
BASF-Test
Principles of method if other than guideline:
Method: BASF-Test. See further details in remarks on materials and methods.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monomethylaethanolamin
- Analytical purity: 99-100 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.8 and 3.0 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as control treated with 0.9 % NaCl (saline).
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
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 - 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 48 h reading is missing
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 48 h reading is missing
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: 48 h reading is missing

Any other information on results incl. tables

Findings animal1/animal2:

 Time Opacity  Iritis  Erythema Chemosis              
1h 3/3 0/0 x/x  0/0              
24h 3/3 0/0 x/x 4/4              
48h  -/- -/- -/- -/-              
72h 3/3 0/0 x/x 4/4              
 8d  3/3 0/0 x/x 4/4              

-: The 48 h reading is missing.

x: a precise evaluation of erythema score was not possible.

Mean values over 24 h and 72 h (48 h reading is missing):

Animal1: Opacity: 3; Chemosis: 4; Erythema: x; Iritis: 0

Animal2: Opacity: 3; Chemosis: 4; Erythema: x; Iritis: 0

The application of the test substance caused within 10 minutes severe corneal opacity and corrosions of the mucous membrane. After 3 days purulent exsudate was noted. At the end of the observation period of 8 days symptoms were still persistent. Severe corneal opacity is considered to be irreversible effect to ophthalmic tissue.

 

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is corrosive
Executive summary:

The test substance is corrosive