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-)]

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:

September 04, 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Orange 074 - Similar Substance 01

IUPAC Name:

Acid Orange 074 - Similar Substance 01

Test material form:

not specified

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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