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EC number: 929-513-6 | CAS number: 1400584-86-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 16 - September 28, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
- EC Number:
- 929-513-6
- Cas Number:
- 1400584-86-2
- Molecular formula:
- C9H13N2O3 · Na
- IUPAC Name:
- sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Crl:KBL(NZW)BR
Test system
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3/female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.88
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- The treatment did not result any effect on body weight.
There were no systemic intolerance reactions.
Any other information on results incl. tables
Summary of Irritant Effects (Score)
Animal |
| 24 h | 48 h | 72 h | Mean scores | Response | Reversible (days) |
1 | Corneal opacity | 0 | 0 | 0 | 0.0 | - | na |
| Iritis | 0 | 0 | 0 | 0.0 | - | na |
| Redness conjunctivae | 2 | 2 | 2 | 2.0 | - | 7 |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | - | 1* |
2 | Corneal opacity | 0 | 0 | 0 | 0.0 | - | na |
| Iritis | 0 | 0 | 0 | 0.0 | - | na |
| Redness conjunctivae | 2 | 2 | 1 | 1.7 | - | 7 |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | - | 1* |
3 | Corneal opacity | 0 | 0 | 0 | 0.0 | - | na |
| Iritis | 0 | 0 | 0 | 0.0 | - | na |
| Redness conjunctivae | 3 | 2 | 1 | 2.0 | - | 14 |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | - | 1* |
response:
corneal opacity : mean scores < 2 = -, ≥ 2 <3 = +, ≥ 3 = ++
irits : mean scores < 1 = -, ≥ 1 <2 = +, = 2 = ++
conjunctival redness : mean scores < 2.5 = -, ≥ 2.5 = +
conjunctival oedema : mean scores < 2 = -, ≥ 2 = +
na : not applicable
*: in respect of the result 1 h post application
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause eye irritation.
- Executive summary:
The irritant / corrosive effects of the test item were tested on the eye of rabbits.
The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002; EEC Directive 67/548 Annex V - Method B.5. (1967) in its current version, and the principles of the EPA Health Effects Test Guidelines (OPPTS 870.2400), United States, EPA 712-C-98-195 (1998), with the exception that recognized differences exist between OECD - Guideline 405 and EPA - Guideline OPPTS 870.2400.
According to classification criteria the test item is not irritating to eyes.
There were no systemic intolerance reactions.
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