Disodium 2,2'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate)

Endpoint summary

Description of key information

The acute oral toxicity was determined with an internal standard procedure. The test substance has a LD₅₀ > 5000 mg/kg bw.

RA - The acute oral toxicity was determined with an internal standard procedure. The test substance has a LD₅₀ > 15000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

November 22, 1976

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Qualifier:

no guideline available

Principles of method if other than guideline:

The test was conducted according to an Internal Method. No other information is available.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150 - 200 g

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5000 mg/kg bw

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

not specified

Interpretation of results:

other: CLP criteria not met

Conclusions:

The acute oral toxicity was determined with an internal standard procedure. The test substance has a LD50 > 5000 mg/kg bw.

Executive summary:

Method:

The Acute Oral Toxicity was determined with an internal standard procedure

Result:

LD₅₀ > 5000 mg/kg bw

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

July 25, 1973

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: between 95 and 105 g.
- Fasting period before study: fasted overnight before treatment
- Housing: housed in groups of 5 in macrolon cages
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

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

Route of administration:

oral: gavage

Vehicle:

water

Doses:

15000 mg/kg bw (only this dose is reported)

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 8 days

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Under these experimental conditions, the test item was practically devoid of toxicity.

Interpretation of results:

other: CLP criteria not met

Conclusions:

The Acute Oral Toxicity was determined with an internal standard procedure. The test substance has a LD50 > 15000 mg/kg bw.

Executive summary:

Method:

The Acute Oral Toxicity was determined with an internal standard procedure.

Conclusion:

LD50 > 15000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 5 000 mg/kg bw

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

Only a short abstract on the "Acute Oral Toxicity" is available for the substance in itself, which doesn’t give enough information for a complete assessment.

Nevertheless another study, which support the result obtained in the above mentioned test, was conducted on an analogue substance. Further information are reported in the Read Across justification attached to section 13.

The first study was performed according to an internal method, whose details are unknown, following oral administration of a single dose of 5000 mg/Kg bw. The LD50 was > 5000 mg/kg bw.

The second study, conducted on the Similar Substance 01, was performed according to an internal procedure, following administration of a multiple doses. Also for this study only a short summary is available. The acute oral LD50 was determined to be > 15000 mg/kg bw.

Considering both the studies on the substance in itself and on the Similar Substance, the effect level is considered to be greater than 500 mg/kg bw.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be > 5000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).