Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(1-methylethoxy)propyl]amino]sulfonyl derivs.

Endpoint summary

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:

2011-2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD guideline compliant study

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)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 15.9 - 19.3 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: 2011-01-19 To: 2011-11-02

Vehicle:

dimethylformamide

Concentration:

10, 25, and 50% (w/w).

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: max 50% in DMF (suspension)
- Irritation: none (blue staining)
- Lymph node proliferation response:

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 with test item concentrations of 10, 25, and 50 % (w/w) in dimethylformamide. 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)

Positive control results:

SI = 8.08
The periodic positive control experiment was performed in August 2011.
Positive control substance: α-Hexylcinnamaldehyde; Vehicle: acetone:olive oil (4+1 v/v)

Parameter:

SI

Remarks on result:

other: Stimulation Indices (S.I.) of 1.04, 1.08, and 1.06 were determined with the test item at concentrations of 10, 25, and 50% (w/w), respectively.

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: mean values: Control 1291.7 10% 1346.7 25% 1390.3 50% 1367.3

No adverse effects on body weight was noted.

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Due to the colour of the test item, redness of the ear skin could not be observered.

The measured ear weights of all animals treated were recorded after sacrifice. A statistically significant or biologically relevant increase in ear weights was not observed in any test item treated group in comparison to the vehicle control group.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In this study the test item was assessed for its skin sensitising potential using the Local Lymph Node Assay (LLNA) in mice according to OECD guidelinge 429 and GLP (BASF 2012). Test item solution was prepared in the vehicle dimethylformamide at concentrations of 10, 25, and 50% (w/w). The highest concentration tested was the highest concentration that could be technically used and applied whilst avoiding systemic toxicity and excessive local skin irritation (as determined by a pre-experiment). The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. Due to the colour of the test item, redness of the ear skin could not be observed. A statistically significant or biologically relevant increase in ear weights was not observed in any test item treated group in comparison to the vehicle control group. Furthermore, the cutoff-value for a positive response regarding the ear weight index of 1.1 reported for BALB/c mice was not exceeded in any dose group. In this study Stimulation Indices (S.I.) of 1.04, 1.08, and 1.06 were determined with the test item at concentrations of 10, 25, and 50% (w/w), respectively. A statistically significant increase in DPM value or in lymph node weight and - cell count was not observed in any test item treated group in comparison to the vehicle control group. Furthermore, the cutoff-value for a positive response regarding the lymph node cell count index of 1.55 reported for BALB/c mice was not exceeded in any dose group. The test item was thus not a skin sensitiser under the test conditions of this study.

Migrated from Short description of key information:
The substance was not sensitising in the LLLNA at doses of 10, 25 and 50% using dimethylformamide as vehicle (BASF 2012)

Justification for selection of skin sensitisation endpoint:
Valid and reliable study.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.