[1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

; the study was conducted with mice (rat is the standard species, recommended in OECD guideline 401).

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): Lionol Green 6YK
- Analytical purity: no data given
- Substance type: fine green powder
- Storage condition of test material: at ambient temperature

Species:

mouse

Strain:

other: HC/CFLP (ICI strain 1)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking and Churchill Ltd., Huntingdon, Cambridgeshire, UK
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 18 - 23 g
- Fasting period before study: overnight prior to and approx. 4 h after dosing
- Housing: allocation to cages within the treatment group; housing in plastic cages with sawdust bedding
- Diet: standard laboratory rodent diet (Scientific Feeds LAD 1 obtained from Special Diet Services Ltd., Witham, Essex, UK), ad libitum
- Water: ad libitum
- Acclimation period: minimum 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 64 %
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Concentration of the test material in vehicle:
- 40 % w/v suspension

- Amount of test material applied per gavage:
- 40 ml/kg bw for 16000 mg/kg bw

The control animals were treated with vehicle alone.

Doses:

0 and 16000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose.

Control animals:

yes

Details on study design:

Animals were observed soon after dosing; then at frequent intervals for the remainder of day 1, On subsequent days the animals were observed at least twice. Clinical signs were recorded at each observation.
All animals were observed for 14 days after dosing and the nature, severitx, approx. time of onset and duration of each toxic sign were recorded.
Individual body weights were recorded on day of dosing (day 1) and on days 8 and 15.
All animals were killed on day 15 and were subjected to a macroscopic post mortem examination.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Mortality:

There were no mortalities.

Clinical signs:

other: Pilo-erection was observed following dosing in all treated mice with recovery apparently completed by day 2.

Gross pathology:

Terminal autopsy revealed no findings.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

There are valid data available for the assessment of the acute oral toxicity of a commerical form of CAS 14302 -13 -7. The study was performed under the Quality Auditing scheme, but a GLP-certificate is not part of the study report. The procedure is consistent with OECD testing guideline 401, but the tested dose of 16 000 mg/kg bw exceeds the limit dose of 2000 mg/kg bw which is required in the EU for classification and labelling. Since no mortality occurred at this excessive high dose, this study can be used as key study despite the lack of purity information. In a limit test each five HC/CFLP male and female mice were administered to single doses of 0 or 16000 mg/kg bw (Huntingdon 1984, Val.2). The animals were observed for 14 d, necropsy was performed with all animals. The LD50 was > 16000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Pilo-erection was observed following dosing in all treated mice with recovery apparently completed by day 2.

In the absence of acute oral toxicity at the limit dose and considering the insolubility, testing for acute dermal toxicity is not required. The pigment is considered to be non toxic at the limit dose in the acute dermal toxicity study.

Justification for classification or non-classification

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. No mortality occurred at 16000 ,mg/kg bw which exceeds the limit dose of 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral or dermal or inhalation toxicity under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.