Benzenesulfonic acid, 2-[2-[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]diazenyl]-4-[[4-chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-, sodium salt (1:2)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 April 1993 to 15 April 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to EU & OECD test guidance in compliance to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

84/449/EEC

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

See below

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test Species: Wistar rat
Strain: HOE: WISKF (SPF71)
Source: HOECHST AG, Kastengrund, SPF breeding colony
Body Weight at start of study: Males: x = 180g (=100%)
s = ± 4g
x min = 175g (-2.8%)
x max = 186g (+3.3%)
n = 5
Females: x = 177g (=100%)
s = ±3g
x min = 173g (-2.3%)
x max = 181g (+2.3%)
n = 5
Age at start of study: Males: approx 7 weeks
Females: approx 8 weeks
Randomisation: Randomisation schemes 404/92 and 617/92
Animal Maintenance: In fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate in groups of 5 animals
Room Temperature: 22 ±3⁰C
Relative Humidity: 55 ±20%
Lighting time: 12 hours daily
Acclimatisation: not necessary (breeding at extensive identical conditions)
Withdrawal of food: from about 16 hours before to 3- 4 hours after treatment
Food: Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe), ad libitum
Water: tap water in plastic bottles, ad libitum
Animal identification: fur-marking with KMnO4 and cage numbering

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionised

Details on oral exposure:

The prepared test substance was administered by gavage to fasted animals at the stated dosage.

Doses:

2000mg/kg body weight

No. of animals per sex per dose:

Males 5, Females 5

Control animals:

no

Details on study design:

Test Groups
The acute oral toxicity of Reaktiv-Gelb F-66 923 FW was tested only at a dose level of 2000 mg/kg body weight.
Five male and five female rats received the test compound as a 20% solution, the application volume being 10 ml/kg bodyweight.
If no compound-related mortality is produced in this limit test according to the guidelines no full study has to be carried out.

Preparation of the test substance
Reaktiv-Gelb F-66 923 FW was dissolved in the stated concentration in deionised water and distributed homogeneously by means of a magnetic stirrer.
Stability and homogeneity of the test substance was determined by analytical methods.

Test procedure
The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: The following clinical signs were observed after the application of Reaktiv-Gelb F-66 923 FW: squatting posture, stilted gait as well as mucous and yellow discoloured feces. From the first day p.a. up to the end of the study the animals were free of sympt

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Other findings:

None detailed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute oral toxicity testing of Reaktiv-Gelb F-66 923 FW in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. in both male and female animals.

Executive summary:

Study conducted to EU test guidance 84/449/EEC part B1 and OECD test guideline 401 in compliance with GLP.

 Acute oral toxicity testing of Reaktiv-Gelb F-66 923 FW in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. in both male and female animals.

 

After application of 2000 mg/kg b.w. no deaths occurred.

 

Clinical signs were observed after application of 2000 mg/kg b.w., consisting of squatting posture and stilted gait. The feces of three animals were mucous and discoloured yellow.

From the first day p.a. up to the end of the study the animals were free of symptoms .

 

Development of body weight was not impaired.

 

The animals killed at the end of the observation period showed no macroscopically visible changes.

 

The substance is not considered harmful.