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

Endpoint summary

Description of key information

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 (Safepharm 1985).

Based on the information in an abstract from 1974 the dermal LD50 is > 4000 mg/kg bw

As the substance does not show toxicity in the acute oral toxicity study, further testing via the dermal route was waived.

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 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

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

Specific details on test material used for the study:

no data on purity of the tested substance

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

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

Preliminary study:

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

worst case estimate as in the available studies limited information on purity is available

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1974

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Qualifier:

no guideline followed

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Type of coverage:

not specified

Vehicle:

not specified

Duration of exposure:

4 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males

Control animals:

not required

Details on study design:

no data

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

act. ingr.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the substance is > 4000 mg/kg bw

Executive summary:

Five male rats received a single dose of 4000 mg/kg bw. The LD50 of the substance is > 4000 mg/kg bw, when corrected for purity of the tested substance

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 000 mg/kg bw

Quality of whole database:

Not assignable, but in absence of effects in the oral study no further testing via the dermal route is considered necessary

Additional information

Based on the information available the substance does not need to be classified for acute toxicity according to Regulation (EC) No 1272/2008.