Ammonium [trisulphamoyl-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Higher doses tested, only 8 days observation

GLP compliance:

no

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., ammonium sodium salts

EC Number:

290-998-6

EC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., ammonium sodium salts

Cas Number:

90295-08-2

Molecular formula:

Unspecified

IUPAC Name:

Copper, [29H,31H-phthalocyaninato(2-)-κN29,κN30,κN31,κN32]-, aminosulfonyl sulfo derivs., ammonium sodium salts

Details on test material:

Pergasoltürkisblau RAL

Specific details on test material used for the study:

FAT 2006 (Pergasoltürkisblau RAL)

Test animals

Species:

rat

Strain:

other: Tif RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: purchased from breeder
- Weight at study initiation: average of 100 g
- Housing: rats were caged in groups of five
- Diet: commercial diet of Nafag
- Water: ad libitum.
- Selection: healthy rats
-Acclimatization: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Photoperiod: 12 hours artificial light and 12 hours darkness.
-Humidity 55%

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized

Details on oral exposure:

10000 mg/kg is 100%
6000 mg/kg is 60% in water
3000 mg/kg bw is 30% in water
1000 mg/kg bw is 10% in water

The tolal volume given was 10 ml/kg body weight

Doses:

1000, 3000, 6000 and 10000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: at the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: reduction in spontaneous motility and ataxia lasting about 60 minutes at 1000 mg/kg bw At higher doses, there was also transient ventricumbency (3000) and muscular hypotonia and hypoventilation (6000 and 10000 mg/kg bw).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 10000 mg/kg bw