Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD guideline compliant 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)

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:

Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)

EC Number:

249-300-5

EC Name:

Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)

Cas Number:

28901-96-4

Molecular formula:

C32H15CuN8O3S.H

IUPAC Name:

Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)

Details on test material:

- purity:>99%
- Name of test material (as cited in study report): Cu-phtalocyanine monosulfonic acid
- Substance type: Blue solid
- Physical state: solid

- Purity test date: 2014
- Lot/batch No.: 130001/RA gemahlen (Laborjournalnr. V12424/RA)
- Expiration date of the lot/batch: February 17, 2034
- Stability under test conditions: stable
- Storage condition of test material: At room temperature, protected against humidity
- Other: The test item appeared to be homogeneous

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 19 - 23.5 g
- Housing: all animals in one group were housed in a cage together as a group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45 – 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2014-05-07 To: 2014-05-02

Study design: in vivo (LLNA)

Vehicle:

other: ethanol / water (3+7 v/v)

Concentration:

2, 5 and 10 % (w/w)

No. of animals per dose:

5

Details on study design:

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: standard H-Methylthymidine incorporation
- Criteria used to consider a positive response: SI > 3

TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by topical (epidermal) application to the dorsal surface
of each ear. The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (diameter 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone.

Positive control substance(s):

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

Results and discussion

Positive control results:

SI = 13.7
The periodic positive control experiment was performed in April 2014
Positive control substance: α-Hexylcinnamaldehyde; Vehicle: acetone:olive oil (4+1 v/v)

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see table 4

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See table 4

Any other information on results incl. tables

Table 1: Lymph Node Cell Counts after Sacrifice
Test item concentration % (w/w)	Animal No.	Lymph Node Cell Count x10E06 per animal	Mean Lymph Node Cell Count x10E06 per animal	SD	Index (Value Test Group versus Value Control
Vehicle Control (EtOH30%)	1	4.07	2.5	0.9	1.00
	2	2.01
	3	2.30
	4	1.85
	5	2.27
2%	6	2.61	2.1	0.5	0.85
	7	2.30
	8	2.09
	9	2.32
	10	1.36
5%	11	2.14	2.5	0.3	0.99
	12	2.43
	13	2.92
	14	2.64
	15	2.25
10%	16	2.51	2.5	0.2	0.99
	17	2.27
	18	2.72
	19	2.19
	20	2.69

Table 2: Lymph Node Weights after Sacrifice
Test item concentration % (w/w)	Animal No.	Lymph Node weight mg per animal	Mean Lymph Node weight (mg)	SD	Index (Value Test Group versus Value Control
Vehicle Control (EtOH 30%)	1	7.24	5.7	1.0	1.0
	2	5.93
	3	5.48
	4	5.41
	5	4.64
2%	6	6.64	5.9	1.0	1.0
	7	6.77
	8	5.46
	9	6.36
	10	4.51
5%	11	5.65	6.3	0.6	1.09
	12	6.62
	13	7.21
	14	5.82
	15	5.97
10%	16	5.37	5.2	0.4	0.90
	17	4.58
	18	5.61
	19	5.06
	20	5.35

Table 3

Test item concentration % (w/w)	Animal No.	Ear weight mg per animal	Mean Ear weight (mg)	SD	Index (Value Test Group versus Value Control)
Vehicle Control (EtOH 30%)	1	24.18	24.9	1.5	1.00
	2	23.08
	3	26.10
	4	24.24
	5	26.73
2.0%	6	26.95	25.7	1.2	1.03
	7	26.80
	8	24.90
	9	24.31
	10	25.67
5%	11	26.51	25.6	0.8	1.03
	12	26.09
	13	24.32
	14	25.39
	15	25.60
10%	16	26.71	26.8	0.8	1.08
	17	26.49
	18	26.95
	19	25.99
	20	28.04

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

.