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

Endpoint summary

Description of key information

Substance is practically non-toxic

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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) .

Preliminary study:

NA

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

9 246 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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 faeceswere 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.