Registration Dossier

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:
other: Comparable to guideline study with acceptable restriction (pre-GLP study).

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)
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyldiaethanolamin
- Analytical purity: 98 %

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 (volume or weight with unit): 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:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no symptoms
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
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

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:
irritating
Remarks:
Migrated information