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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:
27 May 1980 to 27 June 1980
Reliability:
1 (reliable without restriction)
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:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-[(2-chloro-5-sulphonatophenyl)amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzenesulphonate
EC Number:
278-154-5
EC Name:
Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-[(2-chloro-5-sulphonatophenyl)amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzenesulphonate
Cas Number:
75268-65-4
Molecular formula:
C24H21ClFN9O9S2.2Na
IUPAC Name:
disodium 2-[(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazenyl]-4-({4-[(2-chloro-5-sulfonatophenyl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)benzenesulfonate
Test material form:
solid: particulate/powder

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:
PEG 400
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg bw

DOSAGE PREPARATION:
Test substance 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.
Volume (ml/kg body-weight): 10, 20
Doses:
3000, 4000 and 5000 mg/kg bw
No. of animals per sex per dose:
5
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 were calculated by the loglt model.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One female at the dose of 5000 mg/kg bw was found dead 5 hours after the dosing.
Clinical signs:
other: Clinical signs observed included sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position. These were seen at all the used dose levels. The animals recovered within 7 days.
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50 ) in rats was determined to be greater than 5000 mg/kg bw.
Executive summary:

An acute oral toxicity study with FAT 40138/A was 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 substance by gavage. The doses administered were 3000, 4000 and 5000 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 3000 and 4000 mg/kg bw. However, one female at the dose of 5000 mg/kg bw was found dead 5 hours after the dosing. Clinical signs observed included sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position. These were seen at all the used dose levels.The animals recovered within 7 days. The test item administration did not affect body weight gains at any dose levels. Further, no substance related gross organ changes were seen with any of the treated animals. Hence, based on the above findings, the acute oral median lethal dose (LD50 ) in rats was determined to be greater than 5000 mg/kg bw.