Copper, [[[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]amino]sulfonyl]-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Copper, [[[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]amino]sulfonyl]-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts

EC Number:

276-012-7

EC Name:

Copper, [[[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]amino]sulfonyl]-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts

Cas Number:

71786-55-5

Molecular formula:

cannot be displayed for UVCB

IUPAC Name:

Copper, ((((3-((5-chloro-2,6-difluoro-4-pyrimidinyl)amino)phenyl)amino)sulfonyl)-29H,31Hphthalocyaninato (2-)-kappaN29,kappaN30,kappaN31,kappaN32)-, aminosulfonyl sulfo derivs., sodium salts

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Han-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: KFM, CH-4414 Fullinsdorf, Switzerland
- Weight at study initiation: 160-185 g
- Fasting period before study: 18 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Humidity (%): 30%-70%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): Light/dark cycle was 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: WEM

No. of animals per sex per dose:

Five males and five females

Details on study design:

- Duration of observation period following administration: 14 days after dosing
- Frequency of observations and weighing: Observation once in the morning and once in the late afternoon, weighing on day 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, approximate time of death, the nature, severity, approximate time of onset and duration of each toxic sign

Results and discussion

Preliminary study:

A preliminary study was carried out to establish a dosing regimen, using groups of two males and two females at one dosage, using 20 ml/Kg body weight

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

0

Clinical signs:

other: The animals were weak, flaccid and showed a rough coat

Any other information on results incl. tables

Results of the main study

Sex	Dosage mg/kg	Body weight (g) at			Mortality ratio no. of deaths/no. dosed	Time of death after dos. (hours)
		Dosing	1 week	2 weeks
M	5000	179	232	269	0/5	-
F	5000	173	196	202	0/5	-

Applicant's summary and conclusion

Interpretation of results:

other:

Conclusions:

The test substance is acute oral practically non toxic.
LD50 > 5000 mg/kg

Executive summary:

The study was carried out in accordance with OECD Guideline No. 401, "Acute Oral Toxicity".

The substance was administered by oral gavage, to five rats of each sex, at 5000 mg/kg body weight. Macroscopic examination was performed at the end of the experìmental period. Apart from pìloerection, and dark blue urine and faeces noted, no signs of ill health or behaviour changes were seen during the observation period. Macroscopic post mortem examination of the surviving animals at termination revealed greenish discolouration of the glandular stomach, intestines and mesenterial lymph nodes, dark red / black coloured kidneys in all animals, and thickening of the limiting ridge and greenish discolouration of the testes in a few ani ma'ls. The oral LD50 value in rats of either sex was established as exceeding 5000 mg/kg body weight.