Registration Dossier
Registration Dossier
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EC number: 701-133-3 | CAS number: -
Eye irritation
Some information in this page has been claimed confidential.
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 for cross-reference:
- 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
- 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.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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
Data source
Materials and methods
Test material
- Details on test material:
- - Name of test material (as cited in study report): Isononyl Isononanoate
- Physical state: liquid
Constituent 1
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.
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