Registration Dossier
Registration Dossier
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EC number: 202-599-6 | CAS number: 97-65-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Itaconic acid
- EC Number:
- 202-599-6
- EC Name:
- Itaconic acid
- Cas Number:
- 97-65-4
- Molecular formula:
- C5H6O4
- IUPAC Name:
- 2-methylidenebutanedioic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino New Zealand
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Number of animals or in vitro replicates:
- Six male albino New Zealand rabbits
- Details on study design:
- Six male albino New Zealand rabbits were each administered a single ocular dose of 0.1 g of itaconic acid.
The responses were very severe: chemosis (score 4), enanthema (score 3), iris lesion (score 2), and corneal opacity (score 4). Because of the increasing severity in the lesions the study was terminated on human grounds.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Time point:
- other: 1 hrs
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Time point:
- other: 24 hrs
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- iris score
- Time point:
- other: 72 hrs
- Score:
- 2
- Max. score:
- 2
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
