Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

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:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: WHO/VBC 88.953

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts

EC Number:

215-397-8

EC Name:

Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts

Cas Number:

1325-54-8

Molecular formula:

Molecular formula of the main constituents: (1) C38H24N8Na4O12S4 (2) C52H32N10Na6O18S6

IUPAC Name:

decasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{3-sulfonato-4-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Batch Number: 623

Test animals

Species:

rat

Strain:

other: TIf: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 177 to 206g
- Fasting period before study: overnight
- Housing: in Macrolon cages type 4, with standardized soft wood beeding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%):55 ± 10%
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hour /day light cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Administration of the test article: One single oral dose, by gastric intubation (gavage)

VEHICLE
Distilled water
- Concentration in vehicle: 10 ml/kg body weight
- Amount of vehicle (if gavage): 2000 mg/kg
- Lot/batch no. (if required): 623
- Purity: 27%

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg (males and females)
Volume applied: 10 ml/kg bw

No. of animals per sex per dose:

5 males, 5 females (total number of animals: 10)

Control animals:

yes

Details on study design:

Limit test

Observations and records
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days.
Signs and symptoms; daily for 14 days.
Body weight: immediately before administration and on days 7 and 14.
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study.

Clinical signs:

other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests . Additionally, diarrhea was observed in the females. The animals recovered within 5 days.

Gross pathology:

At necropsy, a spotted thymus was found in one female. No deviations from normal morphology were found in the remaining animals.

Any other information on results incl. tables

Dose mg/kg   Number of animals  Number of deaths  Males  2000  5  0  Females  2000  5  0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated , where possible) was determined for the tested material.

LD50 in male rats: greater than 2000 mg/kg body weight
LD50 in female rats: greater than 2000 mg/kg body weight
LD50 in rats of both sexes: greater than 2000 mg/kg body weight

Executive summary:

10 young adult rats (5 males and 5 females Tif: Rai f) were housed in Macrolon cages type 4 and acclimatized at least for 5 days before administration. 2000 mg/kg of the test article solved in water was administrated in one single oral dose by gastric intubation. During 14 days the mortality, signs and symptoms were observed daily. The body weight was measured immediately before administration and on days 7 and 14 of the study and necropsies at the end of the observation period.

In conclusion, after 14 day post-treatment observation period, the LD50 in rats of both sexes is greater than 2000 mg/kg body weight.