Registration Dossier
Registration Dossier
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EC number: 209-987-4 | CAS number: 600-22-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- other: Secondary source ECHA disseminated Dossier for CAS 687-47-8
- Adequacy of study:
- supporting study
- Study period:
- 23 June 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- secondary source
- Title:
- ECHA disseminated dossier for CAS 687-47-8
- Author:
- ECHA
- Year:
- 2 016
- Bibliographic source:
- Study 1995 cited in ECHA disseminated dossier for CAS 687-47-8; Status Dec. 2016
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Version / remarks:
- Chicken Enucleated Eye Test (validated alternative test)
- Principles of method if other than guideline:
- - Burton, A.B.G. (1971) A method for the objective assessment of eye irritation. Food and Cosmetics Toxicology 10, 209-217.
- Burton, A.B.G., M. York and R.S. Lawrence (1981) The in vitro assessment of severe irritants. Food and Cosmetics Toxicology 19, 471-480.
- Commission of the European Communities (1991) Collaborative study on the evaluation of alternative methods to the eye irritaüon test. EC Document XI/632/91, V/E/1/131/91.
- Koëter, H.B.W.M. and M.K. Prinsen (1985) Introduction of an in vitro eye irritation test as a possible contribution to the reduction of the number of animals in toxicity testing. TNO Report V85.188/140322, May 1985, Dept. of Biological Toxicology, TNO Toxicology and Nutrition Institute, Zeist, The Netherlands (available upon request).
- Koëter, H.B.W.M. and M.K. Prinsen (1985) Comparison of in vivo and in vitro eye irritancy test systems: A study with 34 substances. Alternative methods in Toxicology, Volume 3, Chapter A9. Mary Ann Liebert, Inc., publishers.
- Price, J.B.and IJ. Andrews (1985) The in vitro assessment of eye irritancy using isolated eyes.
Food and Chemical Toxicology 23 (2)., 313-315. - Prinsen, M.K.and H.B.W.M. Koëter (1985) EC-Validation study on alternatives to the Draize eye irritation test. Pilot Interlaboratory comparison of the enucleated eye test. TNO Report V89.464, April 1990, Dept. of Biological Toxicology, TNO Toxicology and Nutrition Institute, Zeist, The Netherlands (available upon request).
- Prinsen, M.K. and H.B.W.M. Koëter (1994) Justification of the Enucleated Eye Test with eyes of slaughterhouse animals as an alternative to the Draize eye irritation test with rabbits. Food and Chemical Toxicology, Volume 31, l, 69-76.
- Prinsen, M .K . The Chicken Enucleated Eye Test (CEET): a practical (pre)screen for the assessment of eye irritation/corrosion potential of test materials. Food and Chemical Toxicology, scheduled to be published in Volume 34, no. 4, April 1996. - GLP compliance:
- yes
Test material
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: ROSS, spring chickens
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.03 ml
- Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- 4 hours
- Number of animals or in vitro replicates:
- 4 eyes
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: corneal swelling
- Basis:
- other: Enucleated eye
- Time point:
- other: 240
- Score:
- 3
- Reversibility:
- other: not relevant
- Irritation parameter:
- other: corneal opacity
- Basis:
- other: Enucleated eye
- Time point:
- other: 240
- Score:
- 3
- Reversibility:
- other: not relevant
- Irritation parameter:
- other: fluorescein retention
- Basis:
- other: Enucleated eye
- Time point:
- other: 240
- Score:
- 4
- Reversibility:
- other: not relevant
- Irritant / corrosive response data:
- Thickness of the cornea gradually increased considerably (maximum mean corneal swelling of 31% at 240 min after treatment).
Moderate or severe corneal opacity and severe fluorescein retention (wrinkling of the corneal epithelium).
Applicant's summary and conclusion
- Conclusions:
- Based on the chosen testing conditions, ethyl lactate is considered to be severely irritating to eyes.
- Executive summary:
- On the basis of the results obtained with this in vitro (ex vivo) assay and according to the scheme for classification applied, the following was concluded by the authors :
Ethyl lactate is moderately irritating to eyes, but in view of the additional effects observed, it is recommended to classify ethyl lactate to cause serious eye damage. Based on the structural similarity concerning the alkyl residue (methyl- vs. ethyl group) between Ethyl lactate and Methyl pyruvate and their close metabolic relationship (bilateral biotransformation between pyruvate and lactate via the lactate dehydrogenase), Methyl pyruvate is considered to to cause serious eye damage.via read across.
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