Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

mostly due to reduced reporting in times before GLP, limited data to test substance, read across substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The application volume was not calculated by the individual weight, but by the mean weight per sex

Principles of method if other than guideline:

Standardized test method (BASF-Test)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate

EC Number:

265-634-4

EC Name:

Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate

Cas Number:

65212-77-3

Molecular formula:

C16H12Cl2N4O7S2.Ca

IUPAC Name:

calcium 4,5-dichloro-2-{[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Acclimatization in the animal care unit for at least 1 week.
Age of the animals at the beginning of the study: about 12 weeks
Type of cage: Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
No. of animals per cage: 5
Animal identification: Identification of groups (5 animals) using cage cards
Room temperature: 20 - 26°C
Humidity: 45 - 75%
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Drinking water: Demineralized water each workday, tap water on holidays; ad libitum
Diet: Ssniff R; SSNIFF, Versuchstierdiaeten, Soest, Germany
Fasting period: The animals are given no feed 16 hours before administration, but water is available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% aqueous carboxymethyl cellulose and 1 - 2 drops of Cremophor EL

Details on oral exposure:

Aqueous formulation corresponds to the physiological medium.
Form of administration: suspension

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days
Weight check: Animals of comparable weight (+/- 10 g) in one cage; weighing of groups before administration, 2nd weighing on the 3rd day, 3rd weighing on the 7th day, 4th weighing on the 13th day after administration.
Signs and symptoms: Recording of signs and symptoms < 15 min, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after administration of the test substance and then once each workday. Check for moribund and dead animals twice each workday and once on holidays.
Pathology: Withdrawal of food 16 hours before sacrifice with C02; then necropsy with gross-pathological examination. Necropsy of all animals that die as early as possible.

Statistics:

-

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality, no toxicity observed.

Mortality:

none

Clinical signs:

other: 1 day after treatment: yellow feces

Gross pathology:

Sacrificed animals: organs: no abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met