[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)

Endpoint summary

Description of key information

The substance caused no toxicity in rats upon single oral dosing of 10000 mg/kg bw  (BASF AG, 1976). Based on key study results and experimental data with linear alkylbenzene sulfonate (LAS) salts, the CAS no. 75247-18-6 is considered to be of low acute dermal toxicity with a LD50 above 2000 mg/kg bw (BASF AG, 1976, read across from CAS number 28654-73-1 (for more details please refer to chapter 13 of the IUCLID, Assessment reports); SIAP, 2005).  Similar results were obtained in the acute inhalation toxicity study (BASF AG, 1976). Thereby no mortality was observed (LC0: 13.35 mg/L) and no clinical signs appeared. In a study with mice (BASF AG, 1976) mortality occurred in all dose groups (1470, 2150, 3160 mg/kg bw) after intraperitoneal injection. 

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:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(the applied volume (21.6 mL/kg bw) exceeded 20 mL/kg bw)

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:

TEST ANIMALS
- Weight at study initiation: mean (males): 170 g, mean (females): 160 g

ENVIRONMENTAL CONDITIONS: not reported

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% in water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 46.4% suspension in aqueous CMC preparation (0.5%)

MAXIMUM DOSE VOLUME APPLIED: 21.6 mL / kg bw

Doses:

Dose: 10000 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1 h, 24 h, 48 h, 7 days and 14 days after administration
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed; clinical signs: diarrhea, blue coloured faeces

Mortality:

No mortality was observed.

Clinical signs:

other: Diarrhoe and blue coloured faeces were noted.

Gross pathology:

No adverse effects were observed.

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

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Unsuitable test system (IHT with solid).

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

(exposure for 8 hours, no analytics of distribution, 7 day observation period)

Principles of method if other than guideline:

BASF test (IHT):
The test demonstrates the toxicity of an atmosphere enriched with dust of the test substance at room temperature. Young adult laboratory rats, 6 per sex, were exposed sequentially to the dust generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period.

GLP compliance:

no

Test type:

other: Inhalation hazard test (IHT)

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 193 g (mean)

ENVIRONMENTAL CONDITIONS: not reported

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: No source mentioned; 200 L/h
- Temperature in air chamber: 20°C
- System of generating particulates/aerosols: bubbling 200 L/h air through a substance column

TEST ATMOSPHERE
- Brief description of analytical method used: reweighing of a substance column
- Samples taken from breathing zone: no

VEHICLE:
- composition of vehicle
- concentration of test material in vehicle: 13.35 mg/L (nominal concentration)

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

13.35 mg/L (mean) (Nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure and the amount of air used during the exposure)

No. of animals per sex per dose:

6 rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days

Statistics:

not performed

Sex:

male/female

Dose descriptor:

LC0

Effect level:

13 mg/L air (nominal)

Exp. duration:

8 h

Remarks on result:

other: No animals died. No clinical signs were observed.

Mortality:

No mortality was observed

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No findings.

A strong dust formation was observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Not reliable

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (incomplete documentation, occlusive treatment)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(occlusive treatment)

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:

TEST ANIMALS
- Source: Wiga
- Weight range at study initiation: 135 - 161 g (males); 116 - 119 g (females)

ENVIRONMENTAL CONDITIONS: not reported

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm²
- % coverage: > 10 %
- Site of exposure: right back

REMOVAL OF TEST SUBSTANCE
- Washing: with water containing mild detergent


TEST MATERIAL
- Amount applied: 2500 mg/kg bw (5 mL/kg bw)
- Concentration (if solution): 50 % (in water)
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2500 mg/kg bw

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: before application
- Frequency of observations: daily (on working day) day 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14
- Necropsy of survivors performed: yes

Statistics:

not performed

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality and no clinical signs were observed.

Mortality:

No mortality was observed.

Clinical signs:

other: No local or systemic signs of toxicity were observed. Only substance residues (light-blue) on the skin were seen during the whole observation period.

Gross pathology:

No abnormalities were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 500 mg/kg bw

Additional information

Acute oral toxicity

In the key acute oral toxicity study (BASF AG, 1976, equivalent to OECD 401), groups of 5 Sprague-Dawley rats per dose level were exposed by single oral gavage to the test item (vehicle: carboxymethyl cellulose) of 10000 mg/kg bw (21.6 mL/kg bw). Animals were observed for 14 days. No mortality occurred. Blue colouring of faeces and diarrhea were observed. The oral LD50 was determined to be > 10000 mg/kg bw in male and female rats.

Acute inhalation toxicity

In an acute inhalation toxicity study (BASF AG, 1976) a group of three rats was exposed by inhalation route (whole body) to the test item for 8 hours at a single concentration of 13.35 mg/L (a nominal concentration was calculated as quotient of the amount of test substance weight loss, and the amount of air used during exposure). A control group was treated only with air. Animals then were observed for 7 days. No animal died and no clinical signs were observed.

Acute dermal toxicity

Experimental data on acute dermal toxicity is not available for this substance. Considering the low dermal absorption and the low toxicity upon intraperitoneal injection, no acute hazard for acute dermal toxicity is expected. In addition, experimenteal data showing absence of a hazard is available on the colorant cation (CAS 28654 -73 -1) of the test substance:

In an acute dermal toxicity study (BASF AG, 1976, equivalent to OECD 402) the potential of the structural analogue CAS number 28654 -73 -1 (read across) to exert systemic toxicity was examined in groups of five Sprague-Dawley rats per sex that were occlusively exposed for 24 hours and then observed for 14 days. Animals received 2500 mg/kg bw (5 mL/kg bw). No animal died and no local or systemic signs were observed. The identified LD50 value was > 2500 mg/kg bw in male and female rats.

In addition, experimetal data from acute dermal toxicity studies with the linear alkylbenzene sulfonate (LAS) salts, a chemical category to which CAS no. 75247 -18 -6 belongs to, showed a LD50 value of > 2000 mg/kg bw. This substance represents the anion of the test substance.

Regarding the available data on acute dermal toxicity for LAS salts and CAS no. 28654-73-1 and using a conservative approach, the LD50 of the target chemical CAS no. 75247-18-6 is considered to be at least > 2000 mg/kg bw.

Other route

In an acute toxicity study (BASF AG, 1976) the test item was administered to 5 mice per sex via intraperitoneal injection at dose levels of 1470, 2150 or 3160 mg/kg bw. Observation period was until day 14 following treatment. At the beginning of treatment, a decrease in body weight occurred. Clinical signs were observed like dyspnoe, apathy, spastic movement and bad general conditions. Gross pathology revealed intraabdominal substance deposition and sporadic agglutinations. Based on the mortality incidences of 6/10, 10/10 and 10/10 noted at 1470, 2150 and 3160 mg/kg bw, respectively, the LD50 for the i.p. route of exposure was considered to be approximately 1400 mg/kg bw.

 

Justification for selection of acute toxicity – oral endpoint
most reliable study

Justification for selection of acute toxicity – inhalation endpoint
most reliable study

Justification for selection of acute toxicity – dermal endpoint
most reliable study

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 third time in Directive EC 618/2012.