Polysodium 4-amino-5-hydroxy-3-[{8-hydroxypolysulfonato-7-[{sulfonato-4-[(sulfonatophenyl)diazenyl]phenyl}diazenyl]-2-naphthyl}diazenyl]-6-[(4-nitro-sulfonatophenyl)diazenyl]naphthalenepolysulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 August to 11 September 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

other: RccHan (WIST)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Harlan Laboratories S.r.l., Italy- Age at study initiation: 10-11 weeks old- Weight at study initiation: 174-193g- Fasting period before study: overnight- Housing: group housing, 3 animals per cage- Diet (e.g. ad libitum): ad libitum, except the night before dosing- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 20 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19.7-23.1- Humidity (%): 33-70- Air changes (per hr): 15-20 per hour- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 female animals per dose group

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing: 30 minutes, 1,2,3,4 and 6 hours after dosing and daily for 14 days thereafter- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: skin, fur, eyes, mucous membranes,

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Liquid, dark, purplish discolouration of faeces upto 1 day after dosing. Such observations were not noted from day 2 onwards

Body weight:

No effect

Gross pathology:

No macroscopic observations

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The LD50 of the substance is >2000 mg/kg

Executive summary:

The acute oral toxicity was assessed by gavage dosing to female RccHan (WIST) rats at a dose level of 2000 mg/kg bodyweight according to the OECD 423 test guideline and in compliance with GLP. No mortality or clinical signs were observed and limited clinical effects of discoloured faeces. The LD50 is >2000 mg/kg bodyweight