Registration Dossier
Registration Dossier
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EC number: 240-505-5 | CAS number: 16455-61-1
Eye irritation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- other: Black red, fine grained and free-flowing solid
- Details on test material:
- - Analytical purity: 100 % (UVCB)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No details are available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Amount applied: 69 mg (quantity corresponding to a volume of 0,1 mL)
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 1, 24, 48, 72 hours; to reveal a possible reversibility, readings were continued on Day 7.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24+48+72 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24+48+72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24+48+72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24+48+72 hours
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24+48+72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24+48+72 hours
- Score:
- 0.55
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- No further data available
- Other effects:
- No other effects were noted
Any other information on results incl. tables
|
time |
animal 1 |
animal 2 |
animal 3 |
corneal opacity |
24 h |
2 |
0 |
0 |
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
iris |
24 h |
1 |
1 |
1 |
48 h |
1 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
|
conjunctivae |
24 h |
1 |
1 |
1 |
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
chemosis |
24 h |
1 |
1 |
1 |
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Application of the test article to the rabbit's eye can be designated as not irritant.
- Executive summary:
Eye irritation potential of FeNaEDDHA was evaluated in an eye irritation study according to the OECD guideline 405. The test material (0.1 mL) was applied into the conjunctival sac of the left eye in 3 New Zealand White rabbits. The animals were checked daily for systemic signs of toxicity and mortality. The reactions were fully reversible within 14 days.
The test material can be considered as not irritating to eyes since the mean scores in treated animals are all below the trigger values defined in the EU CLP (Regulation (EC) No. 1272/2008) for classification as eye irritant.
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