3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic acid] hexasodium salt AND 3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:6)

Endpoint summary

Description of key information

In an acute toxic class test female rats were exposed to 2000 mg/kg bw of the substance. No mortality, systemic clinical signs, effects on body weight and macroscopic findings were reported. Blue staining of ears, eyes, tail, feet and snout as well as of the kidney was observed. The LD50 is > 2000 mg/kg bw.

Based on this low toxicity and the very low vapour pressure of the substance (limiting possibilities of inhalation exposure) both the dermal and inhalation studies are 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:

supporting study

Study period:

1987

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Non GLP study on formulation, no definitive conclusion can be drawn

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K. THOMAE GmbH, D-7950 BIBERACH. Germany
- Age at study initiation:
- Average weight at study initiation: 188-198 g
- Fasting period before study: 16 hours (additional fasting period 16 hours before necropsy)
- Housing: 5/Sainless steel wiremesh cage type DKIII
- Diet: KLIBA-LABORDIAET 343 ad libitum (KLINGENTALMUEHLE AG CH-4303 KAISERAUGST, SWITZERLAND)
- Water: tap water ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%):30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

aqua dest.

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium

MAXIMUM DOSE VOLUME APPLIED: not indicated

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily/clinical signs several times on day 1 and daily thereafter, body weight on day 1, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopy

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 666 mg/kg bw

Based on:

act. ingr.

Mortality:

none

Clinical signs:

other: none observed

Gross pathology:

no findings

Interpretation of results:

study cannot be used for classification

Conclusions:

The LD50 of a formulation of the substance is > 5000 mg/kg bw (>1666 mg/kg bw as a.i.)

Executive summary:

Five male and female Wistar rats received a single dose of a formulation of the substance at 5000 mg/kg bw. No effects on mortality clinical signs, body weight and macroscopy were found. The LD50 of the formulation is > 5000 mg/kg bw. Based on a.i. the LD50 is >1666 mg/kg bw. The study does not allow a definitive conclusion on the height of the LD50.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

study is waived based on the low toxicity observed in the acute oral toxicity study (LD50 > 2000 mg/kg bw)

Justification for classification or non-classification

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