Cuprate(4-), [.mu.-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-.kappa.O)-4,1-phenylene]-2,1-diazenediyl-.kappa.N1]]bis[4-(hydroxy-.kappa.O)-2,7-naphthalenedisulfonato]](8-)]]di-, ammonium sodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-04-10 and 1980-05-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: similar to OECD guideline 401, non-GLP conform study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

FAT 11181/A

IUPAC Name:

FAT 11181/A

Test material form:

other: solid

Test animals

Species:

rat

Strain:

other: Tif: RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old
- Fasting period before study: overnight
- Housing: housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.
- Diet: ad libitum; NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2
- Humidity (%): 55 + 10
- Photoperiod: 10 hours light cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg, 20 mL/kg

Doses:

1000, 2000, 3000, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Physical condition and rate of deaths were monitored throughout the whole observation period
- Frequency of weighing: immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 900 mg/kg bw

Based on:

test mat.

95% CL:

2 257 - 3 997

Mortality:

see any other information on results

Clinical signs:

Sedation, dyspnoea, ruffled fur, diarrhoea and a curved body position was observed at concentrations of 1000, 2000 and 3000 mg/kg.
At the highest concentration of 5000 mg/kg ventral and lateral body positions were additionally observed.

Body weight:

Females: Body weight determined on day 1, 7 and 14 remained unchanged.
Males: Slight body weight gain was observed on day 1, 7 and 14 in a concentration range of 1000 - 5000 mg/kg.

Gross pathology:

No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of Deaths

Dose mg/kg	Sex	Total number animals in group	Total Number animals dead	Death rate percentage	Time of death after dosing
					Hours after dosing					Days after dosing
					1	2	3	5	24	2	3	4	5	6	7	14
1000	male	5	0	0
2000		5	2	40					2
3000		5	2	40					2
5000		5	4	80				3						1
1000	female	5	0	0
2000		5	0	0						2
3000		5	3	60					1
5000		5	5	100			1	4