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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

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 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

Due to a technical error the recording of the data of the environment in the animal rooms was disconnected for a few hours due to technical error. This deviation to the study plan, however, does not affect the validity of the study.

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

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

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/CaOlaHsd

Sex:

female

Details on test animals and environmental conditions:

The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.Acclimatisation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
temperature 22 + 2°C
relative humidity 45-65%
artificial light 6.00 a.m. - 6.00 p.m.

Study design: in vivo (LLNA)

Vehicle:

other: Ethanol:deionised water (30+70)

Concentration:

Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 10, 25, and 50% (w/v) in ethanol:deionised water (30+70). The application volume, 25 μl, was spread over the entire dorsal surface (average ~ 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).

No. of animals per dose:

4

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

1.19

Test group / Remarks:

10% group

Results 2

Key result

Parameter:

SI

Value:

0.65

Test group / Remarks:

25% group

Results 3

Key result

Parameter:

SI

Value:

1.23

Test group / Remarks:

50% group

Cellular proliferation data / Observations:

No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Indices of 1.19, 0.65 and 1.23 were determined with the test item at concentrations of 10, 25, and 50% in ethanol:deionised water (30+70). The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3. The test item 5-Aminotetrazol Potassium was not a skin sensitiser under the described
conditions.

Executive summary:

In the study the test item 5-Aminotetrazol Potassium dissolved in ethanol:deionised water (30+70) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50%. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 1.19, 0.65 and 1.23 were determined with the test item at concentrations of 10, 25, and 50% in ethanol:deionised water (30+70), respectively. The test item 5-Aminotetrazol Potassium was not a skin sensitiser in this assay.