Registration Dossier
Registration Dossier
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EC number: 243-001-3 | CAS number: 19372-44-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 April 1999 - 4 June 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD guideline and GLP. The report is however very concise and does not contain full details on methods and results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The report is however very concise and does not contain full details on methods and results.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(pentane-2,4-dionato)calcium
- EC Number:
- 243-001-3
- EC Name:
- Bis(pentane-2,4-dionato)calcium
- Cas Number:
- 19372-44-2
- Molecular formula:
- C10H14CaO4
- IUPAC Name:
- calcium bis[(2Z)-4-oxopent-2-en-2-olate]
- Details on test material:
- Name : Rhodiastab X7
Lot or Batch Number : 9801511
Date received : 9th April 1999
Description : White powder
Container : Clear glass bottle
Storage at RTC : Ambient conditions
RTC reference number: 3807
Purity: 95.0%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1 hour
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
No data
SCORING SYSTEM:
Draize
TOOL USED TO ASSESS SCORE:
No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: the study was terminated after 1 hour
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: the study was terminated after 1 hour
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: the study was terminated after 1 hour
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: the study was terminated after 1 hour
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: the study was terminated after 1 hour
- Irritation parameter:
- cornea opacity score
- Remarks:
- involved area
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: the study was terminated after 1 hour
- Irritant / corrosive response data:
- The study was terminated after a hour as severe irritation was apparent. No further details.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was terminated after a hour as severe irritation was apparent. No further details. Since it is not possible to judge the reversibilty of these effect and the scores at all the highest level the substance is classified corrosive to the eyes.
- Executive summary:
A eye irritation/corrosion study was performed according to OECD guidelines and GLP. In a single animal 0.1 g of test substance was instilled in the eye. The study was terminated after a hour as severe irritation was apparent. No further details. Since it is not possible to judge the reversibility of these effect and the scores are at the highest level the substance is classified corrosive to the eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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