Chromate(2-), [4-[(5-chloro-2-hydroxy-3-nitrophenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 January,1980 to 08 February, 1980.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium[4-{[5-chloro-2-(hydroxy-O)-3-nitrophenyl]diazenyl-N1}-3-methyl-1-phenyl-1H-pyrazol-5-olato(2-)-O][3-{[1-(3-chlorophenyl)-5-(hydroxy-O)-3-methyl-1H-pyrazol-4-yl]diazenyl-N1}-4-(hydroxy-kO)-5-nitrobenzenesulfonato(3-)]chromate(2-)

Cas Number:

72017-66-4

Molecular formula:

C32H19Na2Cl2CrN10O11S

IUPAC Name:

Disodium[4-{[5-chloro-2-(hydroxy-O)-3-nitrophenyl]diazenyl-N1}-3-methyl-1-phenyl-1H-pyrazol-5-olato(2-)-O][3-{[1-(3-chlorophenyl)-5-(hydroxy-O)-3-methyl-1H-pyrazol-4-yl]diazenyl-N1}-4-(hydroxy-kO)-5-nitrobenzenesulfonato(3-)]chromate(2-)

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Test Material: FAT 20202/B
Physical Appearance: Solid
Test Material received date: 02 Januaray 1980

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Age at study initiation: 7 to 8 weeks old
- Housing: Macrolon cages (type 3)
- Diet: ad libitum rat food - NAFAG, Gossau SG
- Water: ad libitum water
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C,
- Humidity: 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

Volume (ml/kg body-weight): 10 and 20
Vehicle: polyethylene glycol (PAG 400); Fluka AG, Buchs SG, Art. 81170

Doses:

2000, 2500, 3000 and 5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations for mortality and clinical signs: daily
- Frequency of weighing: weekly (prior to dosing, day 7 and day 14)
- Necropsy of survivors performed: yes

Statistics:

Probit method

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 696 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 267 - <= 3 095

Mortality:

No mortality was seen at 2000 mg/kg bw, however, % mortality observed was 50 (5 females), 70 (2 males and 5 females) and 100 (5 males and 5 females) at 2500, 3000 and 5000 mg/kg bw, respectively.

Clinical signs:

other: edation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs observed. The surviving animals recovered by day 8.

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of compound FAT 20202/B in rats is 2696 mg/kg bw.

Executive summary:

The acute oral toxicity of FAT 20202/B was evaluated using methodology similar to OECD Guideline 401. In this study, gropus of rats each containing 5 males and 5 females, were administered FAT 20202/B at 2000, 2500, 3000 and 5000 mg/kg bw via gavage. After administration of the compound, the animals were observed for 14 days. No mortality was seen at 2000 mg/kg bw, however % mortality observed was 50 (5 females), 70 (2 males and 5 females) and 100 (5 males and 5 females) at 2500, 3000 and 5000 mg/kg bw respectively. Sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs observed. The surviving animals recovered by day 8. At autopsy no changes caused by the administration of FAT 20202/B were seen.In conclusion, the acute oral LD50 of FAT 20202/B in rats of both sexes observed over a period of 14 days is 2696 mg/kg bw.