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: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(no washing out of the test substance)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oxooel 13
- Physical state: liquid, clear
- Composition of test material: mixture of C13-alcohols, C13-acids and -esters
- Stability under test conditions: yes

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: no data
- Weight at study initiation: mean males: 2.52 kg; female: 2.47 kg
- Housing: single
- Diet: about 130 g per animal and day (Ovator Solikanin 4 mm)
- Water: about 250 ml per animal and day
- Acclimation period: about 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml



Duration of treatment / exposure:
8 days (no washing out of the test substance)
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 (one female, two males)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted

SCORING SYSTEM: as described in OECD guideline 405/Draize


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hrs
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72 hrs
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72 hrs
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72 hrs
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-72 hrs
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
discharge: slightly (two animals)/clearly (one male animal) increased 24 hrs after application, reversible within 48 hrs after application
Other effects:
female: constricted pupil 24 hrs after application, reversible within 48 hrs after application

Any other information on results incl. tables

Cornea Iris Conjunctiva
Animal  Reading  Opacity Area involved Redness Chemosis Discharge Comment
1 24 hrs 0 0 0 2 1 1 PC
2 24 hrs 0 0 0 2 1 2  
3 24 hrs 0 0 0 2 1 1  
1 48 hrs 0 0 0 2 1 0  
2 48 hrs 0 0 0 2 0 0  
3 48 hrs 0 0 0 2 1 0  
1 72 hrs 0 0 0 1 1 0  
2 72 hrs 0 0 0 2 0 0  
3 72 hrs 0 0 0 2 1 0  
1 8 d 0 0 0 0 0 0  
2 8 d 0 0 0 0 0 0  
3 8 d 0 0 0 0 0 0  
mean animal 1-3 24/48/72 hrs 0.0   0.0 1.9 0.8 0.4  
PC pupil contracted

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Due to the redness of the conjunctiva in two of three animals the test substance is classified as irritating to the eyes category 2 according to GHS-EU and category 2B according to GHS-UN.
According to 67/548/EEC, the substance is classified not eye irritating.
Executive summary:

The study is conducted according to OECD Guideline 405 and is reliable (deviation: no washing out of the test substance).

Due to the redness of the conjunctiva in two of three animals the test substance is classified as irritating to the eyes category 2 according to GHS-EU and category 2B according to GHS-UN.

According to 67/548/EEC, the substance is classified not eye irritating.