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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-03-25 - 2008-05-19
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 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
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: 1-H-Tetrazol-5amine-,N-1H-tetrazol-5-yl-, monoammonium salt
Purity: >99%

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Test system: Mice, CBA/CaOlaHsd
Rationale: Recognised as the recommended test system
Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
Number of animals for the pre-test: 2 females
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Age: 8 - 9 weeks (beginning of treatment)
Identification: Single caging. The animals were distributed into the test groups at random and 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.
The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
Housing: single
Cage Type: Makrolon Type I, with wire mesh top
(EHRET GmbH, D-79302 Emmendingen)
Bedding: granulated soft wood bedding
(Harlan Winkelmann GmbH, D-33178 Borchen)
Feed: pelleted standard diet, ad libitum
(Harlan Winkelmann GmbH, D-33178 Borchen)
Water: tap water, ad libitum,
(Gemeindewerke, D-64380 Rossdorf)
Environment: temperature 22 + 3°C
relative humidity 30-70%
artificial light 6.00 a.m. - 6.00 p.m.

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
2.5, 5, and 10%
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Any other information on results incl. tables

Test item concentration

%(w/v)

Group

Measurement DPM

Calculation

Result

DPM-BG

number of lymph nodes

DPM per lymph node

S.I.

BG I

18

BG II

14

1

4593

4577

8

572.1

 

2.5

2

7366

7350

8

918.8

1.61

5

3

9021

9005

8

1125.6

1.97

10

4

9125

9109

8

1138.6

1.99

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the study the test item 1-H-Tetrazol-5amine-,N-1H-tetrazol-5-yl-,monoammonium salt suspended in dimethylsulfoxide was assessed for its possible contact allergenic potential according to OECD Guideline 429.
The test item 1-H-Tetrazol-5amine-,N-1H-tetrazol-5-yl-,monoammonium salt was not a
skin sensitiser in this assay under the described conditions.
Executive summary:

In the study the test item 1-H-Tetrazol-5amine-,N-1H-tetrazol-5-yl-,monoammonium salt suspended in dimethylsulfoxide was assessed for its possible contact allergenic potential according to OECD Guideline 429.

For this purpose a local lymph node assay was performed using test item concentrations of 2.5, 5, and 10%.

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 1.61, 1.97 and 1.99 were determined with the test item at concentrations of 2.5, 5, and 10% in dimethylsulfoxide, respectively.

The test item1-H-Tetrazol-5amine-,N-1H-tetrazol-5-yl-,monoammoniumsalt was not a skin sensitiserin this assay under the described conditions.