1,3,5-Benzenetricarboxylic acid, copper(2+) salt (2:3)

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: GLP- and guideline-conformant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-Benzenetricarboxylic acid, copper(2+) salt (2:3)

Cas Number:

309721-49-1

Molecular formula:

C9 H6 O6 . 3/2 Cu

IUPAC Name:

1,3,5-Benzenetricarboxylic acid, copper(2+) salt (2:3)

Details on test material:

- Name of test material (as cited in study report): 1,3,5-Benzenetricarboxylic acid, copper (2+) salt
- Physical state: solid
- Analytical purity: 98.6g / 100g (100g / 100g minus water content)
- Lot/batch No.: AP199.6
- Storage condition of test material: At room temperature, air sensitive, under nitrogen

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS B.V., Inc. (Netherlands)
- Age at study initiation: 11-12 weeks (pre-test), 8-9 weeks (main study)
- Weight at study initiation: 19.4 +/- 1 g (main study)
- Housing: by group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

propylene glycol

Remarks:

purity 99%

Concentration:

Based on a pre-test with concentrations of 25% and 10% substance, 10% was the highest concentration that could be achieved whilst avoiding local skin irritation. Therefore, the main study was conducted at concentrations of 2, 5, and 10% test substance.

No. of animals per dose:

5

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.74

Test group / Remarks:

2% test substance

Results 2

Parameter:

SI

Value:

4.25

Test group / Remarks:

5% test substance

Results 3

Parameter:

SI

Value:

7.67

Test group / Remarks:

10% test substance

Results 4

Parameter:

EC3

Value:

3.3

Any other information on results incl. tables

The following data were obtained in the local lymph node assay (calculated per group):

Test substance concentration	mean DPM per animal (2 lymph nodes)^$	SD	S.I.
Vehicle control	1169.2	281.5	1.00
2% 1,3,5-Benzenetricarboxylic acid, copper (2+) salt (2:3)	2035.0	800.8	1.74
5%1,3,5-Benzenetricarboxylic acid, copper (2+) salt (2:3)	4965.4	1516.4	4.25
10%1,3,5-Benzenetricarboxylic acid, copper (2+) salt (2:3)	8969.8*	4310.1	7.67

DPM, Radioactive disintegrations per minute

S.I., stimulation index

^$Mean DPM/animal was determined by dividing the sum of the measured values from lymph nodes of all animals within a group by the number of animals in that group (5 animals)

* mean DPM value for the group was significantly higher than the corresponding control value (ANOVA Dunnett-test, p=0.000)

Calculation of the EC3 value:

	Test substance concentration	S.I.
Test group 2	1.58% (a)	1.74 (b)
Test group 3	5%(c)	4.25 (d)
EC3 = (a-c) [(3-d)/(b-d)] + c = 3.3% (w/w)