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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
November 12, 2008 - November 12, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: HET-CAM
Version / remarks:
according to Lüpke (1985) with the modification described by Kalweit (1990)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk

Test animals / tissue source

Species:
other: hen eggs
Details on test animals or tissues and environmental conditions:
- Source: LSL Rhein Main Geflügelvermehrungsbetrieb, 64807 Dieburg, Germany

- The hen eggs were put in an incubator (Grumbach Brutgeräte, Motorbrüter type BSS 160). The trays rotated the eggs four times a day automatically. An optimum breeding temperature of 37.0 ± 1.0 °C and a relative humidity of 65 ± 5 % were maintained. On day 10 the eggs were screened. Eggs, which did not develop a normal vascular system during embryogenesis were discarded.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): tip of a spatula


Duration of treatment / exposure:
300 sec
Details on study design:
On day 10 of incubation the egg shell was opened above the air cell by a dentist's rotary (Micro-Motor type 52601, Albrecht) and a saw (type 321524 2000, Albrecht). The shell with attached outer membrane and inner egg membrane was carefully opened. After the inner membrane had been moistened for about 2 minutes with isotonic sodium chloride solution it was removed to expose the chorioallantoic membrane (CAM) of the fertilized eggs, lying immediately below.
After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (hemorrhage, lysis, and coagulation) over a period of 300 sec.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Run 1
Value:
0
Vehicle controls validity:
not examined
Negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the given experimental conditions, the test material exerted no irritating potential in the HET-CAM test.
Executive summary:

The irritating potential of the test item was determined in the hen's egg test on the chorioallantoic membrane (HET-CAM).This test is routinely used as a screening assay prior to in vivo tests in rabbits. Fertile hen eggs on day 10 of incubation provided the test system.The egg shell was removed around the air cell by means of a dentist drill. The shell with attached outer membrane and inner egg membrane was carefully opened.After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the choriollantoic membrane (CAM) ofthe fertilized eggs, which lies immediately below.

After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (hemorrhage, lysis, and coagulation) over a period of 300 sec. As reference material a 1 % Sodium Dodecyl Sulfate solution was tested and evaluated to ensure the sensitivity of the system.

Under the given experimental conditions, the test material exerted no irritating potential in the HET-CAM test.