Registration Dossier
Registration Dossier
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EC number: 449-430-4 | CAS number: 99189-60-3 1,1-CYCLOHEXANE DIACETIC ACID MONOAMIDE (CAM); 1,1-CYCLOHEXANEDIACETIC ACID MONOAMIDE
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1-cyclohexanediacetic acid monoamide
- EC Number:
- 449-430-4
- EC Name:
- 1,1-cyclohexanediacetic acid monoamide
- Cas Number:
- 99189-60-3
- Molecular formula:
- C10H17NO3
- IUPAC Name:
- 2-[1-(carbamoylmethyl)cyclohexyl]acetic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- single administration of 0.1g of the test item
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the test article application. After the 24 and 48-hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.
- Number of animals or in vitro replicates:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
No general clinical signs were noted in any rabbit.
Locally, at the application site, transiet mild conjuctival redness was mainly observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article administered to rabbits as a single ocular application, is to be considered "non irritant" for the eye.
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