Sodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzene-1-sulphonamidato(2-)]chromate(1-)

Endpoint summary

Description of key information

LD50 > 5000 mg/kg bw

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:

September 11, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: 170 g. (♂), and 145 g. (♀).
- Fasting period before study: 18 hours
- Housing: Rats were caged singly
- Diet: commercial pelleted diet (Oakes Special Diet with added vitamin E) was fed ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2 °C
- Humidity (%): ~50 %
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Route of administration:

oral: gavage

Vehicle:

other: water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 % in water

Doses:

5000 mg/kg b.w

No. of animals per sex per dose:

5 x sex x dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 345 mg/kg bw

Based on:

act. ingr.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

not found

Clinical signs:

No clinical symptoms were recorded

Gross pathology:

no changes in organs or tissues caused by the administration of the test compound were seen.

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

The acute oral median lethal dose (LD50) of test item in rats is greater than 5000 mg/kg b.w (4345 based on active ingr.)

Executive summary:

The substance was tested for acute toxicity by oral route. The compound was tested on 10 healthy Sprague-Dawley derived rats, males and females were segregated individually in a room kept at a constant temperature. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

The acute oral median lethal dose (LD50) of test item in rats is greater than 5000 mg/kg b.w (4345 based on active ingr.)

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

Justification for classification or non-classification

According to the CLP Regulation (EC 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 the 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 greater than 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).

In conclusion, the test substance is non classified for oral acute toxicity, according to the CLP Regulation (EC n. 1272/2008).