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)

Endpoint summary

Description of key information

Skin sensitisation, LLNA - Not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

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)

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%)

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.

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

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

Key result

Parameter:

SI

Value:

ca. 0.9

Test group / Remarks:

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

Key result

Parameter:

SI

Value:

ca. 0.9

Test group / Remarks:

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

Key result

Parameter:

SI

Value:

ca. 1.2

Test group / Remarks:

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

B331 was determined not to be a skin sensitiser (LLNA). On this basis it is concluded that B331 does not meet the criteria as a skin sensitiser in accordance with Regulation (EC) 1272/2008.

No data are available with respect to respiratory sensitisation, but as the substance has been found not to induce skin sensitisation it is considered that the available data does not indicate any concern for a respiratory sensitising effect.