REAKTIV-GELB F-68 072 FW

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:

guideline study

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))

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

Reference substance name:

lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate

EC Number:

413-090-5

Cas Number:

189574-45-6

Molecular formula:

Hill formula: C24H18LixN10NayO12S4

IUPAC Name:

lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate

Test material form:

solid: particulate/powder

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(SPF7l)
Source: HOECHST AG, Kastengrund, SPF breeding colony
Body Weight at start of study: males x = 178 g (= 100 %)
s = ± 2 g
x min = 177 g (- 0.6 %)
x max = 181 g (+ 1.7 %)
n = 5
females x = 176 g (= 100 %)
s = ± 4 g
x min = 170 g (- 3.4 %)
x max = 181 g (+ 2.8 %)
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 ± 3 ⁰C
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 KMn04 and cage numbering

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The acute oral toxicity of Reaktiv-Gelb F-68 072 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% suspension, 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.

Reaktiv-Gelb F-68 072 FW was suspended in the stated concentration in deionised water and distributed homogeneously by means of a magnetic stirrer.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

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

Effect levels

Key result

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-68 072 FW: decreased spontaneous activity, squatting posture, stilted gait, irregular respiration, bristling coat and sunken flanks. From the fourth day p.a. up to the end

Gross pathology:

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

Other findings:

The faeces of all animals were mucous and discoloured orange.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute oral toxicity testing of Reaktiv-Gelb F-68 072 FW in the Wistar rat yielded a median lethal dose above 2000 mg/kg b,w. in both male and female animals.

Executive summary:

The present study was conducted in compliance with OECD Guidelines for Testing of Chemicals, 401"Acute Oral Toxicity"and EEC Guideline B.1, Acute Oral Toxicity in Council Directive 84/449/EEC. This study was conducted in compliance with the Principles of Good Laboratory Practice (GLP).

 

Acute oral toxicity testing of Reaktiv-Gelb F-68 072 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.t consisting of decreased spontaneous activity, squatting posture, stilted gait, irregular respiration, bristling coat and sunken flanks. Furthermore the feces of all animals were mucous and discoloured orange.

From the fourth 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.