Disodium 3-[[2,2'-dimethyl-4'-[[4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxynaphthalene-2,7-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 10th to 26th, 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Red 111

IUPAC Name:

Acid Red 111

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxi-Coop ZRT
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old in first and second step
- Weight at study initiation: 150 - 152 g (at first step); 153 - 159 g (at second step)
- Housing: 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Fasting before treatment: yes, overnight
- Acclimation period: 5 days (first step); 6 days (second step)

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 10 per hr
- Photoperiod: 12 h daily form 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: starting dose was selected on the basis of the available information about the test item.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (first setp)
3 (second step)

Details on study design:

- Duration of observation period following administration: 14 days
- Mortality: animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter.
- General state, external appearance, behavior and clinical symptoms: individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Body weight: the body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
- Necropsy: at the end of the observation period all rats were sacrificed under isofluran anaesthesia. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed, and any abnormality was recorded with details of its location, colour, shape and size.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No death occurred at 2000 mg/kg bw single oral dose of test substance. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.

Clinical signs:

In group 1 treated with 2000 mg/kg bw dose clinical sign of reaction comprised of red faeces (6 cases of 57 observations) and diarrhoea (3/57). Red faeces (score +4, +3) was observed in all animals between 4 hours after the treatment and day 1. Diarrhoea (score +2, +3) was found in all animals on the treatment day 4 hours after the treatment.
In group 2 treated with 2000 mg/kg bw dose clinical sign of reaction comprised of red faeces (6 cases of 57 observations) and diarrhoea (3/57). Red faeces (score +4, +3) was observed in all animals between 4 hours after the treatment and day 1. Diarrhoea (score +2) was found in all animals on the treatment day 4 hours after the treatment.

Body weight:

The mean body weight of animals treated with 2000 mg/kg bw dose corresponded to their species and age throughout the study.

Gross pathology:

All animals treated with 2000 mg/kg bw dose survived until the scheduled necropsy on day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of animals treated with 2000 mg/kg bw dose.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 2000 mg/kg bw.

Executive summary:

The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in 3 female rats.

No death occurred after the single 2000 mg/kg bw oral dose of test substance. As no deaths occurred in the first step, treatment was repeated on 3 further female rats. No animal died in the second step too, so the test was finished.

The observed clinical sign as diarrhoea were related to the effect of the test item. The alteration as red colored faeces was connected with the physical property of test item.

There were not any changes related to the systemic toxic effect of the test item found in body weights and body weight gains during the study.

Autopsy revealed no treatment related pathological changes.

Accordingly, LD50 is > 2000 mg/kg bw.