Reaction mass ofDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN1}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-) andDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN2}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study start date - 11 December 1979; Study completion date - 29 January 1980

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:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

EC Number:

274-487-5

EC Name:

Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Cas Number:

70236-55-4

Molecular formula:

C36H18CrN7O13S.2Na

IUPAC Name:

disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Test material form:

other: solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Code number of the test material used in the study report: 20037/B
- Physical appearance: solid

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house
- Age at study initiation: 7-8 weeks old
- Fasting period before study: Overnight
- Housing: During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.
- Diet: NAFAG, Gossau SG rat food ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 10 hours light cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION: FAT 20037/B was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

4000, 5000, 6000 and 8000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily and weighing Days 1, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen at the dose levels of 4000, 5000 and 6000 mg/kg bw. However, 2 out 5 females died at the dose level of 8000 mg/kg bw.

Clinical signs:

other: Dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs associated with all dose levels. In addition to the above mentioned symptoms, sedation was also observed at the dose level of 8000 mg/kg bw. All the surviving

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 in rats was determined to be greater than 8000 mg/kg bw.

Executive summary:

The acute oral LD50 of the test item was determined in a study conducted according to the methodology that is equivalent to the OECD Guideline 401. Groups of 5 males and 5 females each, were administered the test item diluted in distilled water by gavage. The doses administered were 4000, 5000, 6000 and 8000 mg/kg bw. Clinical signs, mortality check and body weight were recorded during an observation period of 14 days. Animals were submitted to a necropsy whenever they died, survivors at the end of the observation period. No mortality was seen at the dose levels of 4000, 5000 and 6000 mg/kg bw. However, 2 out 5 females died at the dose level of 8000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs associated with all dose levels. In addition to the above mentioned symptoms, sedation was also observed at the dose level of 8000 mg/kg bw. All the surviving animals recovered within 8 days. Further, the test item administration did not affect body weight gains at any dose levels. No substance related gross organ changes were seen with any of the treated animals. Based on the above findings, the acute oral LD50 in rats was determined to be greater than 8000 mg/kg bw.