1H-Benzotriazolium, 1-[bis(dimethylamino)methylene]-, 3-oxide, tetrafluoroborate(1-) (1:1)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08.02.2001 - 14.02.2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-study, but the testarticle was not analyzed for identity, purity, composition or stability

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2001

Materials and methods

Principles of method if other than guideline:

NIH Publication No. 99-4494

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

[(1H-1,2,3-benzotriazol-1-yloxy)(dimethylamino)methylidene]dimethylazanium; tetrafluoroboranuide

Cas Number:

125700-67-6

Molecular formula:

C11H16BF4N5O

IUPAC Name:

[(1H-1,2,3-benzotriazol-1-yloxy)(dimethylamino)methylidene]dimethylazanium; tetrafluoroboranuide

Details on test material:

p.4 under identity of the tested chemical substances: the wrong "Benzotriazol-1-yl-tetramethyluronium tetrafluoroborate"-name is listed for the CAS number 125700-67-6
p.74: The correct name (1H-Benzotriazolium, 1-[bis(dimethylamino)methylene]-, tetrafluoroborate(1-), 3-oxide (9CI) for CAS number 125700-67-6 is given.
however on
p. 84 The "uronium"-names (Benzotriazol-1-yl-tetramethyluronium tetrafluoroborate) are used in the attached safety data sheet

Lot Number: 217152

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

total Number of animals:25,
age: 8-12 weeks,
weight: 18-25 g

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, open

Vehicle:

DMSO

Induction 2

Concentration / amount:

0.5%, 5%, 10%

Challenge

Concentration / amount:

0.5%, 5%, 10%

No. of animals per dose:

5

Positive control substance(s):

yes

Remarks:

DNCB

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

0,1%

No. of animals per dose:

5

Details on study design:

Mice were weighed on Days 1 and 6. Mice were treated on the dorsal surface of both ears, once per day on Days 1,2, and 3. A volume of 25 µl/ear was used. On day 6 the mice were injected i.v. with 20 µCi of ³H-thymidine in 250 µl of saline. Five hours later the mice were euthanized with CO2 and the draining auricular lymph nodes removed.

Positive control substance(s):

other: Dinitrochlorobenzene (DNCB)

Statistics:

f-distribution using SYSTAT(version 9.01, SYSTAT, Inc.). A Dunnetts tesdt was used to determine the degree of significance from control means.

Results and discussion

Positive control results:

stimulation index greater than 3 (5.91)

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 10% - stimulation index 5.11, 5% - stimulation index 2.78, 0.5% - stimulation index 2.80, DNCB- stimulation index 5.91

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: 10% - 6338 (mean) 5% - 3454 (mean) 0.5% - 3476 (mean) DMSO- 1241 (mean) DNCB - 7334 (mean)

Any other information on results incl. tables

no significant changes were found with the body weights.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information

Conclusions:

valid study for classification

Executive summary:

In a skin sensitization study with TBTU (0.5, 5, 10%) in DMSO, female mouse (CBA) were tested in LLNA (using the method of NIH Publication No. 99-4494). TBTU was found to have induced a hypersensitive response in mice, at a concentration of 10% as measured by the proliferation of lymphocytes in the draining lymph nodes. Consequently, TBTU is considered to be a potential sensitizer.