Sodium 3,3'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July 12, 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

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

Test material

Test material information

Constituent 1

Reference substance name:

Acid Blue 080 - Similar Substance 02

IUPAC Name:

Acid Blue 080 - Similar Substance 02

Test material form:

not specified

Test animals

Species:

rat

Strain:

other: Tif: RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 80 to 110 grams.
- Housing: During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages1 (type 3) .
- Diet: standard diet of pellets - No. 890, Nafag Gossau SG, ad libitum
- Water: ad libitum
- Fasting period before study: Animals fasted overnight.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5%
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10, 20, 25, and 30 %

Doses:

1000, 3000, 8000, 10000, 15000 mg/kg

No. of animals per sex per dose:

5 x sex x doses

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95% confidence limits was calculated by the probit analysis method (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. 8 850 mg/kg bw

Based on:

test mat.

95% CL:

ca. 7 960 - ca. 9 900

Remarks on result:

other: 95% confidence limits

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 664 mg/kg bw

Based on:

act. ingr.

Mortality:

yes, for concentrations above 3000 mg/kg

Clinical signs:

other: diarrhea, ditto, reduction in spontaneous motility, ataxia, ventricumbency, muscular hypotonia, hypoventilation. Cyanosis for highest concentration (15000 mg/kg)

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 = 8850 mg/kg bw (5664 mg/kg bw based on active ingtredient)

Executive summary:

Method

The substance has been tested for acute toxicity by oral route. Rats of both sexes were tested at concetration of 1000, 3000, 8000, 10000, 15000 mg/kg by by oral intubation. Physical condition and rate of death were monitored throughout the whole observation period.

Conclusion

The compound has practically no acute toxicity to the rat by this route of administration.