Reaction mass of 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 February 2015 - 17 February 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

not specified

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:

bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane

EC Number:

908-084-9

IUPAC Name:

bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Appearance: Blue powder
Purity: ≥85.5%
Storage conditions: Controlled Room Temperature (15-25oC, below 70 RH%)

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/CaOlaHsd mice

Remarks:

CBA/CaOlaHsd mice

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12 weeks old (age-matched, within one week)
- Weight at study initiation: 19.0-21.3 g (the weight variation in animals in the study did not exceed ± 20% of the mean weight)
- Housing: Group caging / mice were provided with glass tunnel-tubes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-24.8°C
- Humidity (%): 31-69 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

not specified

No. of animals per dose:

4

Details on study design:

PRE-SCREEN TESTS:
- Compound solubility: in DMSO
- Irritation: test item concentrations of 5 and 2.5% (w/v) in DMSO
- Systemic toxicity: none observed
- Ear thickness measurements: yes
- Erythema scores: 0

- Criteria used to consider a positive response: - That exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
- The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.

TREATMENT PREPARATION AND ADMINISTRATION: Freshly prepared in DMSO

Positive control substance(s):

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

Statistics:

not specified

Results and discussion

Positive control results:

Larger than normal lymph nodes were observed in the positive control group. Stimulation index = 6.6
A significant lymphoproliferative response (stimulation index value of 6.6) was noted for HCA in the main experiment. This value was considered to confirm the appropriate performance of the assay

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

ca. 0.9

Test group / Remarks:

B331 (0.5% (w/v) in DMSO)

Results 2

Key result

Parameter:

SI

Value:

ca. 0.9

Test group / Remarks:

B331 (1 % (w/v) in DMSO)

Results 3

Key result

Parameter:

SI

Value:

ca. 1.2

Test group / Remarks:

B331 (2.5% (w/v) in DMSO)

Results 4

Key result

Parameter:

SI

Value:

ca. 1.3

Test group / Remarks:

B331 (5 % (w/v) in DMSO)

Cellular proliferation data / Observations:

CELLULAR PROLIFERATION DATA : The appearance of the lymph nodes was normal in the negative (vehicle) control group and in all test item treated group. Larger than normal lymph nodes were observed in the positive control group (subjective judgement by analogy with observations of former experiments

CLINICAL OBSERVATIONS: No mortality or signs of systemic toxicity. no indications of any irritancy at the site of application

BODY WEIGHTS: No treatment related effects were observed on body weights

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, under the conditions of the present assay, B331, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.