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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:
26. Nov 1968 - 05. Dec 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted prior to the implementation of current testing guidelines and GLP, according to a BASF internal testing method. The study is acceptable and the report well documented, meeting basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

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 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-diethylaminoethanol
- Analytical purity: ca. 99 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.42 and 2.52 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline-control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
Duration of treatment / exposure:
single application, eyes not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: 24 h - 48 h - 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: irreversible damage to corneal tissue (staphyloma).
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: 24 h - 48 h - 72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Remarks:
out of 2 animals
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no symptoms
Irritant / corrosive response data:
Severe findings like hemorrhage into the conjunctivae and purulent exsudates were observed throughout the study period, which were accompanied by conjunctival redness of grade 2 and chemosis of grades 2 to 3. Starting shortly after application corneal opacity was observed which persisted over the study period of 8 days and led to irreversible damage to corneal tissue (staphyloma). The findings indicate severe damage to the eye.

Any other information on results incl. tables

Findings: animal 1/animal 2

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

Applicant's summary and conclusion