Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with (Z)-octadec-9-enylamine (1:1)

Endpoint summary

Description of key information

Information on the substance itself and an analogue substance show that the substance is of low acute oral toxicity in rats. 

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

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP, similar to OECD guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no GLP, less reporting details on housing conditions and test item

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were offered a standardized animal laboratory diet. Food depreviation 15 - 20 h before administration.

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

0.5% aqueous carboxymethyl cellulose preparation
Form of administration: suspension
Test concentration used: 50% (G/V)
Application volume: 10 ml/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: One male died at 5000 mg/kg bw

Mortality:

One male died on study day 8.

Clinical signs:

other: Dyspnea, apathy, abnormal position, staggering, spastic gait, feces blue/green, ruffled fur, diarrhea, exsiccosis, poor general state

Gross pathology:

Animal that died: Heart: acute dilatation on the right side; acute congestive hyperemia
Sacrificed animals: Organs: no abnormalities detected

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

For the substance itself, a study on acute oral toxicity performed prior to the introduction of GLP and OECD testing guidelines was performed (BASF 1980). This study lacks reporting details on the test item and housing conditions, but is otherwise sufficiently similar to OECD testing guideline 423 to allow for hazard assessment. The highest tested dose was 5000 mg/kg bw which exceeds the limit dose of the current test guideline. One animal died as a result of treatment.

In support, information of a close structural analogue is included. For details on structure and a data matrix it is referred to the read-across justification attached to the endpoint summary of skin sensitization and genotoxicity. The analogue substance was tested in a GLP- and OECD 423 compliant study with well-characterized test material. No mortality was observed at the limit dose of 2000 mg/kg bw. This study confirms the low acute oral toxicity of the target substance.

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. No mortality was observed at 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral or dermal or inhalation toxicity 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. No mortality was observed at a 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 fifth time in Directive EC 944/2013.