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

Endpoint summary

Description of key information

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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

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.

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).

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

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)

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity assessment

Three studies are available for the assessment of acute administration by oral route, two of them are on the substance, but lack of many details to be considered enough reliable. The Key study is a study on Similar Substance 02, well descibed and showing a clear dose/response relationship. More details about the similarity between the Target Substance and the Similar Substance 02 are described in the document attached to the IUCLID section 13.

The key study was conducted according to an official OECD method. The substance shows mortality for concentrations above 3000 mg/kg. Clinical signs are reported above 3000 mg/kg bw. The rats shows diarrhea, ditto, reduction in spontaneous motility, ataxia, ventricumbency, muscular hypotonia, hypoventilation. Cyanosis it is observed only for highest concentration (15000 mg/kg bw).

The LD50 value calculated in this test was 8850 mg/kg bw (5664 mg/kg bw based on active ingtredient).

The study performed in 1992 is a short summary, conducted with unknown method. The LD50 was 15000 mg/kg bw.

The study performed in 1973 is conducted with an unknown method. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. The LD50 was 8068.3 mg/kg bw.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- Category 1: ATE ≤ 5 mg/kg bw

- Category 2: 5 < ATE ≤ 50 mg/kg bw

- Category 3: 50 < ATE ≤ 300 mg/kg bw

- Category 4: 300 < ATE ≤ 2000 mg/kg bw

The acute oral LD50 in rats was established to be greater than 2000 mg/kg bw in all tests, therefore the substance is not classified for acute toxicity, according to the CLP Regulation (EC n. 1272/2008).