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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Cross-reference
Reason / purpose:
read-across source
Reference
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:
other: Basic data given. No details on study protocol given as OECD was only cited as the guideline used, the analytical purity of the test substance is not specified.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no details on study protocol
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 3 animals, mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals, mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean over 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
3/3 rabbits had some or obvious chemosis and severe redness (conjunctivae, score 3 of 3) at the 1-hour reading time point (see Table 1). 24 hours after instillation of the test substance, 1/3 rabbits still exhibited some chemosis, which had cleared completely within 48 hours. The severity of the redness was slightly reduced in 2/3 rabbits and remained unchanged in 1/3 rabbits at the 24-hour reading time point. The chemosis was completely reversible within 72 hours. No effects on the cornea or iris were noted at any time point.

Table 1: individual irritation scores

 

Rabbit #

 

Time

 

conjunctivae

 

iris

 

cornea

 

redness

chemosis

1

 

 

 

 

1 h

3

1

0

0

24 h

3

0

0

0

48 h

2

0

0

0

72 h

0

0

0

0

Average*

1.67

0.0

0.0

0.0

2

 

 

 

 

1 h

3

1

0

0

24 h

2

0

0

0

48 h

0

0

0

0

72 h

0

0

0

0

Average*

0.67

0.0

0.0

0.0

3

 

 

 

 

1 h

3

2

0

0

24 h

2

 1

0

0

48 h

1

0

0

0

72 h

0

0

0

0

Average*

1.00

0.33

0.0

0.0

* mean of 24 + 48 + 72 h

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isononyl Isononanoate
- Physical state: liquid

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
3
Reversibility:
not fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
not fully reversible within: 48h

Applicant's summary and conclusion

Conclusions:
Based on all the available data, isononyl isononanoate is not considered to be irritating to the eyes.
Executive summary:

The results of the in vitro eye irritation and corrosion studies of isononyl isononanoate (Boue-Grabot, 2004) as well as an in vivo eye irritation studies with the analogue substance 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) (Dufour, 1990) demonstrate that isononyl isononanoate does not show the potential to cause eye irritation.