Registration Dossier

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

Constituent 1
Chemical structure
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)

Resultsopen allclose all
Parameter:
SI
Value:
1.74
Test group / Remarks:
2% test substance
Parameter:
SI
Value:
4.25
Test group / Remarks:
5% test substance
Parameter:
SI
Value:
7.67
Test group / Remarks:
10% test substance
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)

 

Applicant's summary and conclusion