Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 October 1985 to 19 November 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no data on purity

Data source

Reference

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)

EC Number:

229-158-0

EC Name:

Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)

Cas Number:

6420-33-3

Molecular formula:

C37H28N6Na4O15S4

IUPAC Name:

tetrasodium 3-({4-[({4-[(4,8-disulfonato-2-naphthyl)diazenyl]-2-methoxy-5-methylphenyl}carbamoyl)amino]-5-methoxy-2-methylphenyl}diazenyl)naphthalene-1,5-disulfonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

no data on purity of the tested substance

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna Ltd, Wyton, Huntingdon UK
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 172-200 g; females 172-183 g
- Fasting period before study: overnight until 2 hours post dosing
- Housing: 5/sex/polypropylene cage
- Diet: Rat and Mice Expanded Diet no 1 (Special Diet Srvices Ltd, Witham, Essex UK) ad libitum):
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 40-65%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:clinical signs and mortality : after 1 and 4 hours and daily thereafter
- Body weight: on day 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Preliminary study:

Hunched posture, piloerection and diarrhea on day 1 at 2000 and 5000 mg/kg bw
No mortality

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

Hunched posture, piloerection and diarrhea on day 1

Body weight:

within normal ranges

Gross pathology:

no effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the substance tested the LD50 is >5000 mg/kg bw.

Executive summary:

In an acute oral study, rats (5/sex) received the substance by oral gavage at 5000 mg/kg bw. No effects on mortality, bodyweight or macroscopy were found after the 14 day observation period. On day 1 of the test hunched posture, piloerection and diarrhea were observed. The LD50 is > 5000 mg/kg bw.