Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-10-25 and 1994-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-conform study, method according to OECD guideline 401 and method B1 of Commission Directive 92/69/EEC, 49% mixture was tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]

EC Number:

241-769-4

EC Name:

Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]

Cas Number:

17791-81-0

Molecular formula:

C60 H46 N16 Na6 O22 S6

IUPAC Name:

4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-(4-morpholinyl)-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(2-phenyldiazenyl)-2,7-naphthalenedisulfonic acid] hexasodium salt

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, U.K.
- Age at study initiation: approx. 5 to 8 weeks
- Weight at study initiation: males 150 - 160 g, females 148 - 166 g
- Fasting period before study: overnight fast immediately before dosing, approx. 2 h after dosing
- Housing: housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: rat and mouse expanded diet no. 1, special diets services limited, Witham, Essex, U.K., ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 48 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 1/2, 1, 2 and 4 hours after dosing, subsequently once daily; weighing: before experiment, on day 7 and 14
- range-finding study was performed to define the dose level for the main study
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight

Statistics:

not required

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

act. ingr.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systematic toxicity were noted during the study. Dark red staining of the fur was noted in all males from 1-hour observation to the day 1 observation, and in one female at the 4-hour and 1 day observations.

Gross pathology:

No abnormalities were noted at necroscopy.