5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 June to 23 August 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Internal Guideline Hoechst AG

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt

EC Number:

287-842-4

EC Name:

5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt

Cas Number:

85586-40-9

Molecular formula:

C29H19N3Na4O17S5 C29H23N3O17S5.xNa

IUPAC Name:

5-(Benzoylamino)-4-hydroxy-3-((1-sulpho-6-((2-(sulphooxy)ethyl)sulphonyl)-2-naphthyl)azo)naphthalene-2,7-disulphonic acid, sodium salt

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Remazolbrillantrot F3B AKA-Muster

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG - own breeding
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 80 to 127 g (females)
- Fasting period before study: 16 hours before to 2 hours after dosing
- Housing: in groups
- Diet: Altromin 1324 ad libitum
- Water: tap ad libitum
- Acclimation period: NA

IN-LIFE DATES: From: 30 June to 23 August 1976

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% (250 mg/mL)
- Amount of vehicle (if gavage): 20 mL/kg

Doses:

6300, 8000, 10000, and 15000 mg/kg bw

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: clinical signs multiple times on day one, thereafter twice daily; body weight: weekly
- Necropsy of survivors performed: yes

Statistics:

Die LD 50 wurde mittels einer Probitanalyse (Methode nach LINDER und WEBER) bestimmt; die Vertrauensgrenzen wurden nach CAVALLI-SFORZA berechnet (Abt. f. Prakt. Mathematik der Hoechst Aktiengesellschaft) .

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

9 246 mg/kg bw

Based on:

test mat.

95% CL:

8 306 - 10 293

Remarks on result:

other: no gender-related differences were noted in preliminary tests

Mortality:

No animals died at 6300 mg/kg
3, 6, and 10 rats died at 8000, 10000, and 15000 mg/kg, respectively

Clinical signs:

other: no clinical signs in surviving rats. Dying rats showed diarrhea, tonic-clonic convulsions and prone position prior to death.

Gross pathology:

At necropsy of deceased rats, all inner abdominal organs were red discoloured.
Necropsy of terminal rats revealed a slightly violet discolouration of skin, subcutis and cartilages.

Other findings:

Urine and feces were reddish discolored in all animals.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral medial lethal dose was calculated by Probit analysis to be 9246 mg/kg bw in female Hoe:WISKf(SPF71) rats

Executive summary:

The test substance was tested for acute oral toxicity in 10 female Wistar rats per dose group. The test substance was administered as a single dose of 6300, 8000, 10000, and 15000 mg/kg bw by gavage after a 16-hour fasting period. The animals were observed for 14 days for signs of toxicity and body weight development.

Died rats, or surviving rats at the end of the observation period underwent necropsy and macroscopical evaluation. Dying rats showed diarrhea, tonic-clonic convulsions and prone position prior to death. Urine and faeces were reddish discoloured in all animals. At necropsy of deceased rats, all inner abdominal organs were red discoloured. Necropsy of terminal rats revealed a slightly violet discolouration of skin, subcutis and cartilages. No animals died at 6300 mg/kg, 3, 6, and 10 rats died at 8000, 10000, and 15000 mg/kg, respectively. The LD50 was calculated by Probit analysis to be 9246 mg/kg bw.