Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
EC Number:
406-640-0
EC Name:
A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
Cas Number:
136920-07-5
Molecular formula:
C58H114N4O6 - C154H308N6O4
IUPAC Name:
Reaction mass of 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C12-C18)alkylacetamide and {[2-(Carboxymethyl-di(C12-C18)alkylcarbamoylmethyl-amino)-ethyl]-di(C12-C18)alkylcarbamoylmethyl-amino}-acetic acid
Constituent 2
Reference substance name:
Keroflux ES 3241
IUPAC Name:
Keroflux ES 3241
Details on test material:
- Lot No.: T 75492/ST 1414/90, Part 1
- Physical state: solid, light beige; after heating at about 50°C: liquid, yellow
- Date of manufacturing: 1990-10-10
- Storage stability: at about 8°C

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, D
- Weight at study initiation: 3.22 kg (male), 3.28-3.96 kg (females)
- Housing: single in stainless steel cages with wire mesh walk floors
- Diet: KLIBA 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, CH; 130 g/ day
- Water: tap water; 250 mL/ day
- Acclimation period: at least 8 days


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml of the test substance cooled down to body temperature
Duration of treatment / exposure:
Single application; the substance was not washed out
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Readings: 1 h, 24 h, 28 h, 72 h after application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 -72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Other effects:
Slight to moderate discharge was observed in 2 of the three tested animals which reversed fully within 72 h.

Applicant's summary and conclusion