Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

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
Details on test material:
- Name of test material (as cited in study report): Tributylamin

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenach, Germany
- Weight at study initiation: 2.78, 2.66, 2.78 kg
- Housing: single
- Diet: KLIBA 341, 4mm; klingentalmuehle AG, CH, ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Duration of treatment / exposure:
Single application - eyes were not washed out
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Maximum score is the sum of individual findings for one animal.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Given score is the mean value for all three time points.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Given score is the mean value for all three time points.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Given score is the mean value for all three time points.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Findings animal1/animal2/animal3:

 Time     Conjunctiva                 
Opacity  Iritis Erythema Chemosis              
1 h 0/0/0    0/0/0   2/2/2  0/0/0              
24 h 0/0/0  0/0/0  2/1/2  0/0/0              
48 h 0/0/0  0/0/0  1/1/1  0/0/0              

72 h

0/0/0    0/0/0  0/0/0  0/0/0              

Mean values over 24, 48, and 72 h:

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

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

Animal3:Opacity: 0; Iritis: 0; Erythema: 1; Chemosis: 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test the test item was not irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008.
Executive summary:

A reliable experimental study was performed with three rabbits (BASF AG, 1985; similar to OECD 405, RL 2, key study). Animals were exposed to 0.1 mL of neat test item and were observed for 72 hours. At the 1, 24, 48 and 72 h reading there were no effects on the cornea, iris and no conjunctivia chemosis was observed (score 0 for all endpoints at all time points). Only a mean conjuctiva redness score of 0.9 (mean of all animals; 24 -48 -72 h) was observed, effects were fully reversible within 72 h, thus the test item is not irritating to the eyes.