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: see 'Remark'
Remarks:
Comparable to OECD guideline study. Acceptable, well documented report which meets basic scientific principles. Study was conducted before establishment of the OECD Test Guideline, but study protocol is in principle similar to OECD TG 405, with acceptable restrictions (only 50 µL instilled, only 2 animals used, observation period only 8 days).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Only 50 µL instilled, only 2 animals used, observation period only 8 days.
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. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tri-2-Aethylhexylamine
- Physical state: liquid
- Analytical purity: approx. 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: 3.06 and 3.19 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
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms
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:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms

Any other information on results incl. tables

Findings animal 1/2:

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

Mean values over 24h, 48h and 72h:

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

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

The application of the test substance caused slight reversible erythema to the eyes of the exposed animals.

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information