2H-Tetrazol-5-amine, N-2H-tetrazol-5-yl-, ammonium salt (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-04-16 - 2008-05-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-280-6

EC Name:

-

Cas Number:

303749-96-4

Molecular formula:

Hill formula: C2H6N10 CAS formula: C2H3N9.H3N

IUPAC Name:

N-(1H-1,2,3,4-tetrazol-5-yl)-1H-1,2,3,4-tetrazol-5-amine amine

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name 1H-Tetrazol-5-amine-, N-1H4etrazol-5-yl-, monoammonium salt
Appearance white powder
Composition 1H-Tetrazol-5amine-, N-1H-tetrazol-5-yl-, monoammonium salt
CAS-No. 303749-96-4
EINECS-No. not stated
Molecular formula C2H6N10
Molecular weight 170.14 g/mol
Purity > 99 %

Test animals / tissue source

Species:

other: in vitro

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

25 mg

Duration of treatment / exposure:

300 seconds

Number of animals or in vitro replicates:

not applicable

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 300 seconds

Score:

2.42

Max. score:

21

Reversibility:

not specified

Any other information on results incl. tables

Observations

Test Group	Time until Haemor­rhage (s)	Time until Lysis (s)	Time until Coagulation (s)	Irritation Score	Mean Irritation Score
Negative Control	301	301	301	0.00
Negative Control	301	301	301	0.00	0.00
Negative Control	301	301	301	0,00
Positive Control	14	26	34	19.21
0.1 NaOH
Positive Control 0.1 NaOH	17	30	37	18.98	19.00
Positive Control	15	28	45	18.82
0.1 NaOH
Positive Control 1 % SDS	8	59	301	10.53
Positive Control 1 % SDS	9	88	301	9.84	10.07
Positive Control	A	91	301	9.85
1% SDS
Test Item	160	301	301	2.35
Test Item	134	301	301	2.78
Test Item	167	301	301	2.23	2.42
Test Item	149	301	301	2.53
Test Item	169	301	301	2.20
Test Item	156	301	301	2.42

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The in vitro skin irritation potential of 1H-Tetrazol-5-amine-, N-1 H-tetrazol-5-yl-, monoammonium salt was determined according to OECD Guideline 405.
The test item 1H-Tetrazol-5-amine-, N-1 H-tetrazol-5-yl-, monoammonium salt showed slight effects on the blood vessels of the CAM, calculated mean irritation score is 2.42.
In conclusion, it can be stated, that in this study and under the experimental conditions reported, the test item 1H-Tetrazol-5-amine-, N-1H-tetrazol-5-yl-, monoammonium salt possesses a slight irritation potential.

Executive summary:

The in vitro skin irritation potential of 1H-Tetrazol-5-amine-, N-1 H-tetrazol-5-yl-, monoammonium salt was determined according to OECD Guideline 405.

One valid experiment was performed.

Hen's eggs with an age of nine days were used. The test item 1 H-Tetrazol-5-amine-, N- 1 H-tetrazol-5-yl-, monoammonium salt was brought onto the surface of the CAM of a hen's egg which had been incubated at 37 °C for nine days. Observation time was five 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.

The positive controls (1% solution of SDS and 0.1 n NaOH) induced a moderate or severe irritation, respectively, on the blood vessels.

The test item 1H-Tetrazol-5-amine-, N-1 H-tetrazol-5-yl-, monoammonium salt showed slight effects on the blood vessels of the CAM, calculated mean irritation score is 2.42.

In conclusion, it can be stated, that in this study and under the experimental conditions reported, the test item 1H-Tetrazol-5-amine-, N-1H-tetrazol-5-yl-, monoammonium salt possesses a slightirritation potential.