Registration Dossier

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
Study period:
23 - 24 Apr 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1987
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
Limited documentation, no in vivo testing rationale
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-octyldodecyl isooctadecanoate
EC Number:
298-361-4
EC Name:
2-octyldodecyl isooctadecanoate
Cas Number:
93803-87-3
Molecular formula:
C38H76O2
IUPAC Name:
2-octyldodecyl isooctadecanoate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: 8 weeks
- Weight at study initiation: 1.49-1.58 kg
- Housing: individually housed in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, the Netherlands), approximately 100 g/day. Hay (BMI, Helmond, the Netherlands) was provided once a week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 Feb 1998 To: 26 Feb 1998

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was not washed after application

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: during the 24-hour reading time point, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal and the extent of corneal epithelial damage was assessed using a UV-light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point (see Table 1).
Other effects:
There was no mortality, and no clinical signs were observed during the study period.

Any other information on results incl. tables

Table 1: Eye irritation scores

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

1 (AB)

0

0

0

24

1 (A)

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

2

 

 

 

 

1

1 (ABC)

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.00

0.0

0.0

0.0

3

 

 

 

 

1

1 (AB)

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.00

0.0

0.0

0.0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average

score

1

1.00

0.00

0.00

0.00

24

0.33

0.00

0.00

0.00

48

0.00

0.00

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.11

0.00

0.00

0.00

A = eyelids

B = nictating membrane

C = sclera

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.

Categories Display