Registration Dossier

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:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 kg (mean)

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: 50 µL
Duration of treatment / exposure:
single application - eyes were not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
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. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Irritant / corrosive response data:
In the rabbit eye, 50 μL undiluted methyldiethanolamine caused redness, swelling and clouding of the cornea as well as conjunctival bleeding. The symptoms had disappeared after 8 days.

Any other information on results incl. tables

Table 1: Findings animal1/animal2:

 Time     Conjunctiva   

Opacity 

Iritis

Erythema

Chemosis

1 h

3/3

0/0

2/2

2/2

24 h

1/1

0/0

2/2

1/1

48 h

1/1

0/0

2/2

1/1

72 h

1/1

0/0

1/1

0/0

8 days

 0/0

 0/0

 0/0

 0/0

Mean values over 24, 48, and 72 h:

Animal1: Opacity: 1; Iritis: 0; Erythema: 1.7; Chemosis: 0.7

Animal2: Opacity: 1; Iritis: 0; Erythema: 1.7; Chemosis: 0.7

In the rabbit eye, 50 μL undiluted methyldiethanolamine caused redness, swelling and clouding of the cornea as well as conjunctival bleeding. The symptoms had disappeared after 8 days.

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

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria