Diphosphoric acid, zinc salt, compd. with 1,3,5-triazine-2,4,6-triamine (1:1:2)

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:

other: Study conducted to OECD guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (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

Test material information

Constituent 1

Reference substance name:

Reaction products of 1,3,5-triazine-2,4,6-triamine and zinc bis(dihydrogen phosphate)

EC Number:

690-512-6

Cas Number:

1271172-98-5

Molecular formula:

Zn(C3H7N6)2(P2O7)

IUPAC Name:

Reaction products of 1,3,5-triazine-2,4,6-triamine and zinc bis(dihydrogen phosphate)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 19.7 - 23.1 g
- Housing: Housed by group in labelled makrolon cages with granulated softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard diet fed ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 31-65%
- Photoperiod (hrs dark / hrs light): 12 hours light 12 hours dark cycle

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

solvent control, 10, 25 and 50 % (w/w)

No. of animals per dose:

4

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (1 per day)
- Exposure period: Days 1-3
- Test groups: 2, 3 and 4
- Control group: 1
- Site: Dorsal surface of both ears (25 uL per ear)
- Frequency of applications: Once per day (each ear) at approximately the same time each day
- Concentrations: 10, 25 and 50 % (w/w)

Five days after the first topical application of test substance (day 6), each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) containing 19.7 μCi of 3H-methyl thymidine. After approximately 5 hours animals were killed and the nodes excised and pooled per group.

Single cell suspensions (in PBS) of pooled lymph node cells were prepared by gentle mechanical disaggregation through a stainless steel gauze. After washing twice the cells were resuspended in 5% trichloroacetic acid and incubated at approximately 4°C for at least 18 hours for precipitation on macromolecules. The precipitates were then resuspended in 5% trichloroacetic acid and trasnferred to scintillation vials with scintillation liquid and mixed. The levels of 3HTdR incorporation were measured on a B-scintillation counter along with background measurements. The results were provided in the form of radioactive disintergrations per mintue (dpm).

Positive control substance(s):

not specified

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.21

Test group / Remarks:

10%

Results 2

Parameter:

SI

Value:

1.87

Test group / Remarks:

25%

Results 3

Parameter:

SI

Value:

1.81

Test group / Remarks:

50%

Results 4

Parameter:

EC3

Remarks on result:

not determinable because of methodological limitations

Results 5

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Control: 320.9 10 %: 388.7 25%: 601.6 50%: 580.8

Any other information on results incl. tables

Clinical signs: the animals did not show any signs of systemic toxicity or local skin irritation during the course of the test.

Body weights: All bodyweight measurements were within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on these results, the test substance would not be regarded as a skin sensitizer according to the recommendations made in the test
guidelines. The test substance does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact
according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (as amended) and the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (as amended).