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Toxicological information

Acute Toxicity: oral

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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

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.