2H-Tetrazol-5-amine, potassium salt (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

The eggs were 10 days in the heating chamber, because the ninth day was a Sunday.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

potassium 5-amino-1H-1,2,3,4-tetrazol-1-ide

Cas Number:

136369-04-5

Molecular formula:

CH2KN5

IUPAC Name:

potassium 5-amino-1H-1,2,3,4-tetrazol-1-ide

Test material form:

solid: particulate/powder

Details on test material:

Batch no.: 08KI030

Test animals / tissue source

Species:

chicken

Details on test animals or tissues and environmental conditions:

Freshly laid Lohmann Leghorn chicken eggs were obtained from the LSL Rhein Main Geflügelvermehrungsbetrieb (Dieburg, Germany) ten days before the start of the test. Then the eggs were incubated at 37.0 ± 0.5 °C for ten days (arrived on 23. Jan. 2009). During incubation, the eggs were gently rotated to prevent an attachment of the embryo to one side of the egg.

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.2986 g of the test item was given on the membrane in such a manner that 50% of the surface of the membrane were covered with test item.

Number of animals or in vitro replicates:

6 for test item, 3 for controls

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

ca. 11.84

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

This in vitro study was performed to assess the irritating potential of 5-Aminotetrazol Potassium by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (ten days old). Observation time was 5 minutes at room temperature. Physiological sodium chloride solution was used as negative control, sodium dodecyl sulfate (1% solution ) and sodium hydroxide (0.1-n solution) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. A mean irritation score of 19.69 was calculated for the positive control NaOH. This value is considered as valid, because the positive control showed a clear severe irritation. The upper threshold of 19 is not mandatory in the guideline. The negative control showed no irritation, the irritation score for the positive control SDS lay within the demanded range. The test item was tested pure. A mean irritation score of 11.84 was calculated, corresponding to a classification as “severely irritant”. No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.

Executive summary:

One valid experiment was performed. Hen’s eggs with an age of ten days were used. The test item 5-Aminotetrazol Potassium was brought onto the surface of the CAM of a hen’s egg which had been incubated at 37 oC for ten 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 membrane. Solutions of Sodium Dodecyl Sulfate (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 5-Aminotetrazol Potassium showed severe effects on the blood vessels of the CAM. The calculated mean irritation score is 11.84. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item 5-Aminotetrazol Potassium possesses severe irritation potential.