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Administrative data

Endpoint:
eye irritation
Remarks:
other: Hen´s Egg Test on the Chorioallantoic Membrane (HET-CAM)- reaction time method
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Shortly documented, scientifically good . According to GLP and to Alternative methods currently available to the Draize rabbit eye test

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Hen´s Egg Test Chorioallantoic Membrane (HET-CAM) test permits the identification of irritative reactions which appear to be similar to those which occur in the eye using the standard Draize rabbit eye test. In the HET-CAM test system, three reactions are determined: haemorrhage, lysis and coagulation of the chorio-allantoic membrane at the ninth day of embryonation when nerve tissue and pain perception have not yet developed.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc bis(dihydrogen phosphate)
EC Number:
237-067-2
EC Name:
Zinc bis(dihydrogen phosphate)
Cas Number:
13598-37-3
Molecular formula:
Zn(H2PO4)2
IUPAC Name:
zinc bis(dihydrogen phosphate)
Test material form:
other: solution
Details on test material:
- Name of test material: zinc bis(dihydrogenphosphat) or zinkphospat-lösung 2
- Physical state: colorless, clear
- Lot/batch No.: SAT060237
- Expiration date of the lot/batch: 04.07.2009
- Storage condition of test material: roomtemperature

Test animals / tissue source

Species:
other: hen's eggs
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: eggs treated with reference substance
Amount / concentration applied:
0.3ml of the 10% mixture of the test article (1g of test article was mixed with distilled water to a total volume of 10ml)
Duration of treatment / exposure:
5 minutes
Observation period (in vivo):
5 minutes
Number of animals or in vitro replicates:
6 White Leghorn eggs per test substance

Results and discussion

In vivo

Results
Irritation parameter:
other: relativ irritation potential
Basis:
mean
Score:
0.99
Remarks on result:
other: relativ irritation potential (Q)
Other effects:
No other effects

Any other information on results incl. tables

 Substance (undiluted) Conc (% free H3PO4)  SAT (intern batch nr)  relativ irritation potential (Q)  SD  ± Assessment 
phosphorsäure  4.5  060236 0.96 0.13  moderately irritating *
 zinkphospat-lösung 2 (zink-bis-dihydrogenphosphat, 14.6%) 4.5 060237 0.99   0.05 moderately irritating *
 zinkphospat-lösung 2, verdünnt (faktor 1.72 mit wasser) (zink-bis-dihydrogenphosphat, 14.6%) 2.6  060252  0.99  0.09  moderately irritating *
 referenzsubstanz 'Texapon ASV' 5% AS 050359 1.00  0.04  moderately irritating

* extravasale Koagulationsnachweis: positiv

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test substance, zinkphospat-lösung 2 (zink-bis-dihydrogenphosphat, 14.6%), as undiluted, is moderately irritating. Slight extravasale coagulation is assessed.
Executive summary:

The aim of this study is to evaluate the potential ocular irritancy of a test substance as measured by its ability to induce toxicity in the chorioallantoic membrane of a hen. Effects are measured by the onset of: (1) hemorrhage; (2) coagulation; and (3) vessel lysis. These assessments are considered individually and then combined to derive a score, which is used to classify the irritancy level of the test substance.

Based on the relative irritation potential (Q), the test substance, as undiluted, is moderately irritating