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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The analytical purity of the test substance was not reported.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Journal Officiel, 21.04.1971, amended on 05.06.1973
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Oct 2012
Deviations:
yes
Remarks:
analytical purity not reported
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-octyldodecyl myristate
EC Number:
245-205-8
EC Name:
2-octyldodecyl myristate
Cas Number:
22766-83-2
Molecular formula:
C34H68O2
IUPAC Name:
2-octyldodecyl myristate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: the animals are housed individually in polystyrene cages (540 mm x 360 mm x 315 mm) with a perforated polystyrene floor
- Diet: 150 g complete maintenance food, granulés lapin Entretien '117' (UAR, Villemasson/Orgel, France)
- Water: softened and filtered drinking water, ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): minimum 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
Single instillation without rinsing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48 and 72 h, and 4 and 7 days
Number of animals or in vitro replicates:
6 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: opthalmoscope; supplemetary assessments are performed using a hand-slit lamp, if necessary

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3 and #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal: #3, #5 and #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
At the 1-h reading time point 6/6 rabbits had slight to moderate conjunctivae and chemosis (score 1 – 2), and effects on the iris (score 1). At the 24-h reading time point, slight conjunctivae (score 1) was observed in 1/6 rabbits, and slight chemosis (score 1) was seen in 4/6 other rabbits. Chemosis (score 1) was still present in 1/6 rabbits 48 h after instillation. Iris effects were observed in 2/6 animals at the 24-h reading time point, persisting in 1/6 until 48 h after instillation. All eye irritation effects had cleared completely within 72 h. No cornea opacity was observed in any rabbit at any time point (see Table 1).

Any other information on results incl. tables

Table 1. Individual eye irritation scores

Rabbit #

 

Time

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1 h

1

1

1

0

24 h

0

0

0

0

48 h

0

0

0

0

72 h

7 d

0

0

0

0

0

0

0

0

Average*

0.0

0.0

0.0

0.0

2

 

 

 

 

1 h

1

2

1

0

24 h

1

0

0

0

48 h

0

0

0

0

72 h

7 d

0

0

0

0

0

0

0

0

Average*

0.33

0.0

0.0

0.0

3

 

 

 

 

1 h

2

2

1

0

24 h

0

1

0

0

48 h

0

0

0

0

72 h

7 d

0

0

0

0

0

0

0

0

Average*

0.0

0.33

0.0

0.0

4

 

 

 

 

1 h

2

2

1

0

24 h

0

1

1

0

48 h

0

0

1

0

72 h

7 d

0

0

0

0

0

0

0

0

Average*

0.0

0.33

0.67

0.0

5

 

 

 

 

1 h

2

2

1

0

24 h

0

1

0

0

48 h

0

0

0

0

72 h

7 d

0

0

0

0

0

0

0

0

Average*

0.0

0.33

0.0

0.0

6

 

 

 

 

1 h

1

2

1

0

24 h

0

1

1

0

48 h

0

1

0

0

72 h

7 d

0

0

0

0

0

0

0

0

Average*

0.0

0.67

0.33

0.0

*(24h+48h+72h)/3

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.