Tin titanium zinc oxide

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:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: U. S. EPA Health Effects Test Guidelines OPPTS 870.2600

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Experimental Toxicology and Ecology, BASF AG

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-430-0

EC Name:

-

Cas Number:

923954-49-8

Molecular formula:

SnxZnyTi2Oz with x = 0,5 – 1,7 y = 0,5 – 1,7 z = 5,5 – 7,5

IUPAC Name:

oxygen titanium zinc λ²-stannane

Details on test material:

- Test-substance No.: 07/0285-1
- Analytical purity: 99.61 g/100 g (analytical report No. 07L00144)
- Lot/batch No.: GV 33900-66
- Stability under test conditions: regarding the precision of the methods used, the test item showed no significantly differences to the characterization 07L00144

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 6 – 12 weeks
- Weight at study initiation: 19.5 g – 22.6 g
- Housing: single housing in Makrolon cage, type II
- Diet (e.g. ad libitum): Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (LLNA)

Vehicle:

propylene glycol

Concentration:

3, 10, 50%

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS:
The selection of concentrations took into account available information on the chemical/physical properties, the composition and on acute toxicity and primary irritation/corrosion potential of the test substance. Additionally, the results of a pretest with a 50% test substance preparation were considered, which showed slightly increased ear weights and lymph node weights as indication of ear irritation. The 50% preparation was the maximum technically applicable concentration.


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Murine Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: The increase SI of cell count by a factor of >1.5 and/or of 3H-thymidine incorporation by a factor of ≥ 3 as compared to the concurrent vehicle control group is generally considered as indicating a sensitizing potential of a test substance


TREATMENT PREPARATION AND ADMINISTRATION:
- Body weight determination: individual body weights on day 0 prior to the first application and on day 5 prior to the sacrifice of the animals.
- Signs and symptoms: no detailed clinical examination of the individual animals was performed but any obvious signs of systemic toxicity and/or local inflammation at the application sites were noted in the raw data.
- Form of application: epicutaneous application is simulating dermal contact with the compound which is possible to occur under practical use conditions.
- Application volume: 25 μL per ear
- Site of application: dorsal part of both ears
- Frequency of application: 3 consecutive applications (day 0 – day 2) to the same application site
- Observations: twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
- ³H-thymidine injection: on study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μl of sterile saline into a tail vein
- Terminal procedures: the animals were sacrificed on study day 5 about 5 hours after 3H-thymidine injection by cervical dislocation.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: ³H-thymidine incorporation [DPM/Lymph Node Pair]: - control: 254.3 +/- 58.4 - 3%: 250.6 +/- 84.2 - 10%: 301.5 +/- 83.6 - 50%: 525.7 +/- 141.8 - positive control: 1225.6 +/- 453.6

Results 2

Parameter:

SI

Value:

1

Test group / Remarks:

animals 1-5, 0%

Results 3

Parameter:

SI

Value:

0.99

Test group / Remarks:

aniamls 6-10, 3%

Results 4

Parameter:

SI

Value:

1.19

Test group / Remarks:

animals 11-15, 5%

Results 5

Parameter:

SI

Value:

2.07

Test group / Remarks:

animals 16-20, 50%

Results 6

Parameter:

SI

Value:

4.82

Test group / Remarks:

animals, 21-25, positive control

Any other information on results incl. tables

Results:

Test group	Treatment	Cell Counts [Counts/Lymph Node Pair]
		Mean	SI
1	vehicle	6222600 ± 528453	1.00
2	3%	8026800 ± 3292733	1.29
3	10%	7702800 ± 767852	1.24
4	50%	9681600 ± 2860637	1.56
5	positive control	14400000 ± 2083175	2.31
Test group	Treatment	3H-thymidine incorporation [DPM/Lymph Node Pair]
		Mean	SI
1	vehicle	254.3 ± 58.4	1.00
2	3%	250.6 ± 84.2	0.99
3	10%	301.5 ± 83.6	1.19
4	50%	525.7 ± 141.8	2.07
5	positive control	1225.6 ± 435.5	4.82
Test group	Treatment	3H-thymidine incorporation [DPM/Lymph Node Pair]
		Mean	SI
1	vehicle	4.5 ± 0.3	1.00
2	3%	5.2 ± 1.3	1.15
3	10%	5.1 ± 0.5	1.12
4	50%	5.7 ± 1.0	1.26
5	positive control	7.9 ± 0.9	1.73

SI: stimulation index

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information