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)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 August 2005 to 14 September 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to the guideline under GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: CD (Crl: CD(SD) IGS BR
- Source: Charles River UK Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation:
- Fasting period before study: overnight (and 3-4 hours after dosing)
- Housing: 3/solid floor propylene cage (with woodflakes and enrichment materials)
- Diet: Certified Rat and Mouse Diet (code 5LF2) ad libitum (BCM IPS Ltd, London, UK)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): > 15/hour
- Photoperiod (hrs dark / hrs light):12/12

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 groups of 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/clinical signs after 0.5, 1, 2,and 4 hours and daily thereafter; bodyweight on day 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopy

Statistics:

NA

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: blue staining of urine on day 1-2 blue staining of ears, eyes, tail, feet and snout on day 1-5/6 (until termination in 1 female)

Gross pathology:

blue staining of the kidney

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the substance is > 2000 mg/kg bw

Executive summary:

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