Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: HET-CAM-TEST following OECD 405 Draft Guideline dated 24.4.2002
Deviations:
no
Principles of method if other than guideline:
The in vitro study was performed to assess the irritating potential of a test item by detection of damages in blood vessels under the chorionallantoic membran (CAM) of incubated chicken eggs (nine days old). The study is performed for notification according to Chemical Act.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: Lohmann Leghorn chicken eggs
Strain:
other: Lohmann Leghorn

Test system

Vehicle:
physiological saline
Controls:
no
Observation period (in vivo):
5 min.

Results and discussion

Any other information on results incl. tables

 Test group  Mean irritation score  Classification
 Negativ Control  00.00  not irritant
 Positive Control (0.1 n NaOH)  19.70  severely irritant
 Positive Control (1 % SDS)  10.23  severely irritant
 Test Item B 1061  10.29  severely irritant

The positive controls induced a severe irritation on the blood vessels. The negative control showed no irritation, score for the positive control lay within the demanded range.

The test item B 1061 was tested pure. A mean irritation score of 10.29 was calculated, corresponding to a classification as severely irritant.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test item B 1061 showed severe irritation in the HET-CAM-Test.
Executive summary:

One valid experiment was performed.

Hen's eggs with an age of nine days were usedr.

The test item B 1061 was brought onto the surface of the CAM of a hen's egg which had been incubated at 37.5 +-0.5 °C for nine days.

Observation time was 5 minutes at room temperature.

Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the blood vessels under the membran.

Solutions of SDS (1 %) and NaOH (0.1 n) were used as positive controls. The positive controls induced a severe irritation on the blood vessels.

The test item B 1061 showed severe irritation on the blood vessels of the CAM. The calculated mean irritation score is 10.29.