Registration Dossier
Registration Dossier
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EC number: 485-280-6 | CAS number: 303749-96-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-04-04 - 2008-05-13
- 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:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- 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 %
Constituent 1
Test animals
- Species:
- other: in vitro
- Strain:
- not specified
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 25 mg
- Duration of treatment / exposure:
- 1 hour
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: %Formazane production
- Basis:
- mean
- Time point:
- other: 2 min
- Score:
- 100.4
- Reversibility:
- no data
- Irritation parameter:
- other: %Formazane production
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 108.4
- Reversibility:
- no data
Any other information on results incl. tables
Absorption Values |
Negative Control |
Test Item |
Positive Control |
|
|||
Tissue1 |
Tissue2 |
Tissue1 |
Tissue2 |
Tissue1 |
Tissue2 |
|
1.442 |
1.516 |
1.530 |
1.570 |
0.316 |
0.327 |
3 min |
1.562 |
1.636 |
1.553 |
1.559 |
0.311 |
0,323 |
|
1.581 |
1.562 |
1.541 |
1.584 |
0.313 |
0.318 |
|
1.429 |
1.395 |
1.481 |
1.579 |
0.186 |
0.182 |
1 hour |
1.299 |
1.465 |
1.461 |
1.550 |
0.182 |
0.183 |
|
1.394 |
1.426 |
1.472 |
1.570 |
0,191 |
0.198 |
|
Mean |
Mean |
Mean |
|
|||
1.550 |
1.556 |
0.318 |
3 min |
|||
1.402 |
1.519 |
0.189 |
1 hour |
|||
Test Item |
Positive Control |
|
100.4 |
20.5 |
3 min |
108.4 |
13.3 |
1 hour |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Skin Corrosion Potential of 1H-Tetrazol- 5-amine-, N-1 H-tetrazol-5-yl-, monoammonium salt in the Human Skin Model Test following OECD 431 was determined. After treatment with the test item, the relative absorbance values had decreased to 100.4% after three minutes treatment. This value is well above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values had risen to 108.4 %. This value is far above the threshold for corrosion potential (15%), too.
Therefore, 1H-Tetrazol-5-amine-, N-1 H-tetrazol-5-yl-, monoammonium salt is considered as "not corrosive" in the Human Skin Model Test. - Executive summary:
The Skin Corrosion Potential of 1H-Tetrazol- 5-amine-, N-1 H-tetrazol-5-yl-, monoammonium salt in the Human Skin Model Test following OECD 431 was determined.
One valid experiment was performed.
Two tissues of the human skin model EpiDerm™ were treated with for three minutes and one hour, respectively. 25 mg of the solid test item were applied to each tissue and spread to match the tissue size.
Deionised water was used as negative control, 8m KOH was used as positive control.
After treatment with the negative control, the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals, thus showing the quality of the tissues.
After treatment with the test item, the relative absorbance values had decreased to 100.4% after three minutes treatment. This value is well above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values had risen to 108.4 %. This value is far above the threshold for corrosion potential (15%), too.
Therefore, 1H-Tetrazol-5-amine-, N-1 H-tetrazol-5-yl-, monoammonium salt is considered as"not corrosive"in the Human Skin Model Test.
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