Hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)

EC Number:

276-657-4

EC Name:

Hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)

Cas Number:

72428-99-0

Molecular formula:

C32H13CuN8O4S2.(SO3H)m.(C4H11NO)n.(C8H18N) (3-m-n).C15H17N3

IUPAC Name:

hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf/Switzerland
- Age at study initiation: males: 7 weeks; females: 9 weeks
- Weight at study initiation: males: 171 - 202 g; females: 156 - 169 g
- Fasting period before study: 12 - 18 hours
- Housing: caged in groups of five in Macrolon cages type 3 with wire mesh tops
- Diet: pelleted standard Kliba 343, Batch 70/82; rat maintenance diet (Klingentalmuehle AG, 4303 Kaiseraugst / Swi tzer 1an d) ( ad libitum):
- Water: tap water (ad libitum):
- Acclimation period: 1 week under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2
- Humidity (%): 55+-10
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2 I. solution of CMC (carboxymethylcellulose natriumsalt purum in distiled water

Doses:

1000 mg/kg bw as 10 ml suspension
5000 mg/kg bw as 20 ml suspension

No. of animals per sex per dose:

5 mles and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily and weighing: day 0, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: slight sedation, slightly curved body position, slightly ruffled fur at males and females on day 1

Gross pathology:

no pathologic changes at males and females for both concentrations

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 is greater than 5000 mg/kg bw

Executive summary:

The substance was tested for acute oral toxicity according to OECD guideline 401. The substance was administered to 10 rats (5 males, 5 females) in two concentrations (1000 and 5000 mg/kg bw). No mortality was observed but the following main symptoms:

ruffled fur, sedation, dyspnoea, curved body position. These symptoms disappeared after day 2 of the 14 days observation period.

Development of the body weights was normal. In the necropsy no macroscopic organ changes were observed.

The LD50 value was estimated to be greater than 5000 mg/kg bw