Disodium 3,3'-[cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis(4,6-dihydroxynaphthalene-2-sulphonate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read across from similar substacne

Adequacy of study:

key study

Study period:

June 6, 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted testing procedures.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

similar substance 01

IUPAC Name:

similar substance 01

Test animals

Species:

rat

Strain:

other: Tif RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: no data- Age at study initiation: young- Weight at study initiation: 100 g- Fasting period before study: fasted overnight- Housing: They were housed in groups of 5 in macrolon cages (Size 3)- Diet: standard diet of Nafag ad libitum- Water: drink water , ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1 °C- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

1000, 3000, 6000, 10000, 15000 mg/kg bw

No. of animals per sex per dose:

5 per sex per doses

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days - Frequency of observations and weighing: Symptoms and mortality were monitored but the frequency was not specified- Necropsy of survivors performed: no data

Statistics:

The LD50 was calculated by probit analysis method (maximum likelyhood, Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 955 mg/kg bw

Based on:

test mat.

95% CL:

ca. 3 960 - ca. 6 200

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 1 000 mg/kg bw

Based on:

test mat.

Mortality:

yes, for doses above 1000 mg/kg

Clinical signs:

reduction in spontaneous motility, slight ataxia, diarrhea, ditto, hypoventilation.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The acute oral LD50 in rats was calculated to be 4955 mg/kg bw.

Executive summary:

The substance has been tested for acute short-term toxicity by oral route. Rats of both sexes were tested at concentration of 1000, 3000, 6000, 10000, 15000 mg/kg bw by oral intubation. Physical condition and rate of death were monitored throughout the whole observation period. The symptoms during the 15 days of observation period are: reduction in spontaneous motility, slight ataxia, diarrhea, ditto, hypoventilation. The compound has therefore practically no acute toxicity to the rat by this route of administration.