Reaction mass of Sodium, bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]chromate(1-) and sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1Hpyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)]

Endpoint summary

Description of key information

LD50 = 7700 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 04, 1974

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)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred under SPF conditions in CIBA-GEIGY.
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g.
- Fasting period before study: one night before starting the treatment
- Housing: housed in Macrolon cages (Type 3) in groups of 5
- Diet (e.g. ad libitum): NAFAG, Gossau SG, rat food ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): approx. 50

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 % with polyethylene glycol

Doses:

4640, 6000, 7750 mg/kg bw

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: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 7 700 mg/kg bw

Based on:

test mat.

Mortality:

one animal died within 24 h

Clinical signs:

Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur.

Gross pathology:

No substance related gross organ changes were seen.

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 = 7700 mg/kg bw

Executive summary:

Method

The acute oral LD50 of the test substance in rats of both sexes was observed over a period of 14 days, according to a procedure similar to the OECD guideline 401.

Results

LD50 = 7700 mg/kg bw

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), 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 both tests, therefore the substance is not classified for acute toxicity, according to the CLP Regulation (EC n. 1272/2008).