Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Endpoint summary

Description of key information

The substance was found to be non-hazardous upon gavage dosing of rats and it was of low toxicity upon intraperitoneal injection of 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:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP, deviations from OECD guideline, reported with sufficient detail.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

7 days observation period, doses much higher, higher number of animals per dose group

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight: males 234 g, females 191 g

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Aqueous suspension with CMC
Test concentration used: 30% (G/V)

Doses:

8000 and 10000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

None

Clinical signs:

other: Dyspnea

Gross pathology:

Sacrificed animals: nothing abnormal detected

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

10 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1972

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: only orientating information about the inhalation hazard. Poorly characterized test atmosphere.

Principles of method if other than guideline:

Whole body exposure to dust generated by blowing air through a layer of the test substance.

GLP compliance:

no

Test type:

other: inhalation hazard test

Species:

rat

Sex:

male/female

Route of administration:

inhalation: dust

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

ca. 8

Concentrations:

Mean concentration: 8.29 mg/l

No. of animals per sex per dose:

12

Control animals:

yes

Details on study design:

Whole body exposure to dust generated by blowing air through a layer of the test substance.
Temperature 20°C
Air flow: 200L per hour
Strong dust generation observed.

Sex:

male/female

Dose descriptor:

LC0

Effect level:

>= 8.29 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: Concentration determined by weight difference of test substance layer at the beginning and at the end of the exposure period.

Mortality:

None

Clinical signs:

other: Slight mucosal irritations; fur intense blue-coloured

Gross pathology:

Sacrificed animals: organs: nothing abnormal detected

Interpretation of results:

relatively harmless

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Insufficient characterization of test substance in the atmosphere.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

In the acute oral toxicity study in rats, the substance was applied as an aqueous suspension at doses of up to 10000 mg/kg bw to each five male and female rats. The animals were observed for 7 days and then subjected to necropsy. This procedure deviates from the OECD testing guideline in the shorter observation period. Considering that the doses applied are up to five times higher than the limit dose in the OECD guideline and that no adverse effects were observed, the shorter observation period is acceptable.

Intraperitoneal injection of rats resulted in mortality at high doses. The LD50 for this route of application was determined at 2000 mg/kg bw.

According to ECHA guidance r7a (Aug 2014) testing for acute dermal toxicity is indicated if: systemic toxicity is observed in skin/eye irritation and/or skin sensitisation studies; if death is observed in an acute oral toxicity test and there is potential for dermal absorption, if

systemic toxicity is observed in an acute oral toxicity test and if there is potential for high dermal absorption.

None of these criteria is fulfilled in case of this substance. The substance did not cause mortalities after a single oral dose of 10000 mg/kg bw. Its molecular weight exceeds 500 g/mol and its water solubility is very low. Skin absorption is considered to be absent or very low. No skin sensitization potential was detected in the LLNA (BASF 2015). Overall, based on the acute toxicity data and the physico-chemical properties, it can be concluded that the substance is non-hazardous for acute dermal toxicity without further animal testing.

Justification for selection of acute toxicity – inhalation endpoint
Only study available

Justification for selection of acute toxicity – dermal endpoint
Absence of an acute dermal toxicity hazard can be determined without further testing.

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 acute oral or dermal or inhalation toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/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 acute oral or dermal or inhalation toxicity under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.