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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

pentalithium(1+) pentasodium 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

EC Number:

939-992-3

Cas Number:

1195028-55-7

Molecular formula:

Molecular formula of the main constituents: (1) C38H28N8O12S4.xLi.xNa (2) C52H38N10O18S6.xLi.xNa

IUPAC Name:

pentalithium(1+) pentasodium 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:

other: liquid form

Details on test material:

Lot/batch No.:2619427

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: autorised supplier
- Age at study initiation: young and healthy rats
- Weight at study initiation: 208 to 231 g
- Fasting period before study:
- Housing: Makrolon (48 x 27 x 20 cm) Tecniplast brand.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21° C ( ± 2 °C)
- Humidity (%): 55% (±25%)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/2

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The sample is diluted 1/10 with water
MAXIMUM DOSE VOLUME APPLIED: 1.69 ml per 100 g of body weight, equivalent to 2000mg/kg bw

Doses:

2000 mg/kg
This is a limit test, and the information available suggests that the substance is practically non toxic. If after 14 days of the test there isn't mortality observed the test can be finished.

No. of animals per sex per dose:

3 males and 3 females.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: every day
- Necropsy of survivors performed: yes
- Other examinations performed: skin, hair, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavioral patterns.
-Special attention to: tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

Not observed

Clinical signs:

other: All behaviours registered are considered normal. Not toxicity signs are atributed to the administration of the test material All animals administered, alive with normality until 14 observation days.

Gross pathology:

Observation at necropsy didn't show significant macroscopic changes in any of the animals.

Any other information on results incl. tables

Mortality in the limit test (male rats, 2000 mg/kg)

Rat n°	Volum administered	Initial	Death	Remarks
ML1	3.6	03/01/03	17/01/03	Sacrified to 14 days
ML2	3.9	03/01/03	17/01/03	Sacrified to 14 days
ML3	3.5	03/01/03	17/01/03	Sacrified to 14 days

Mortality in the limit test (female rats, 2000 mg/kg)

Rat n°	Volum administered	Initial	Death	Remarks
ML1	2.8	31/12/02	14/01/03	Sacrified to 14 days
ML2	2.9	31/12/02	14/01/03	Sacrified to 14 days
ML3	2.9	31/12/02	14/01/03	Sacrified to 14 days

Weight in the limit test (male rats, 2000 mg/kg)

	Weight in grams
Rat	Initial	7° day	Final	Remarks
ML1	215	280	309	---
ML2	231	297	320	---
ML3	208	284	313	---

Weight in the limit test (female rats, 2000 mg/kg)

	Weight in grams
Rat	Initial	7° day	Final	Remarks
ML1	164	198	207	---
ML2	170	195	214	---
ML3	171	198	215	---

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The tested substance presents an acute toxicity by oral route in rats of LD50 >2500 mg/kg.

Executive summary:

After 7 days of acclimatization, a limit dose of 2000 mg/kg bw was administered in several phases in order to analise the presence of letality to 6 rats (3 males and 3 females).

An individual weight control and general examinations during the observation period of 14 days were performed.

It can be concluded that the tested substance presents an acute toxicity LD 50 >2500 mg/kg according to the results presented in the study.