Registration Dossier
Registration Dossier
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EC number: 601-722-4 | CAS number: 120570-77-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- CHEMICAL BURNS OF THE RABBIT CORNEA
- Author:
- Carpenter, C.P. and Smyth, H.F.
- Year:
- 1 946
- Bibliographic source:
- Am J Ophthalmol. 29(11):1363-72
Materials and methods
- Principles of method if other than guideline:
- Treatment of the rabbit eye with differing volumes of the undiluted test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethylene diformate
- EC Number:
- 211-077-7
- EC Name:
- Ethylene diformate
- Cas Number:
- 629-15-2
- Molecular formula:
- C4H6O4
- IUPAC Name:
- 2-formyloxyethyl formate
- Details on test material:
- - Name of test material (as cited in study report): Ethylene glycol diformate
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino rabbit, not further specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.02 and 0.005 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- Reading time point: 18-24 h
- Number of animals or in vitro replicates:
- 5
- Details on study design:
- SCORING SYSTEM: The individual numerical scores of each eye treated with a given volume or concentration of a chemical were added together and then divided by the number of eyes to obtain the score of the injury caused by the treatment. The level of 5 was selected as representative of severe injury. This figure corresponded to necrosis, visible after staining and covering about 3/4 of the surface of the cornea; or a more severe necrosis covering a smaller area.
See Tables 1 and 2 under "Any other information on materials and methods incl. tables".
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: injury grade
- Basis:
- mean
- Remarks:
- out of 5 eyes
- Time point:
- other: 18-24 h
- Score:
- 5
- Max. score:
- 20
- Reversibility:
- not specified
- Remarks on result:
- other: 0.005 mL of the undiluted test substance
- Irritation parameter:
- other: injury grade
- Basis:
- mean
- Remarks:
- out of 5 eyes
- Time point:
- other: 18 - 24 h
- Score:
- > 5
- Max. score:
- 20
- Reversibility:
- not specified
- Remarks on result:
- other: 0.02 mL of the undiluted test substance
Applicant's summary and conclusion
- Interpretation of results:
- other: classification based on Regulation 1272/2008, Eye Damage 1, H318
- Conclusions:
- CLP: Eye damage 1, H318
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