Disodium 3(or 5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylate

Endpoint summary

Description of key information

According to the acute oral toxicity study results the value of LD50 of the test substance, Direct Black 51, for female rats is higher than 2000 mg/kg of body weight. Acute toxicity studies via dermal or inhalation exposure are not available.

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:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: SPF breeding, VELAZ, Únětice, Czech Republic (RČH CZ 21760118)- Age at study initiation: 8 - 10 weeks- Weight at study initiation: 133 - 175 g- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage with sterilized shavings of soft wood- Diet (e.g. ad libitum): pelleted standard diet for experimental animals ad libitum- Water (e.g. ad libitum): drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature: 22 ± 3°C (permanently monitored)- Humidity: 30 – 70 % (permanently monitored)- Photoperiod: 12-hour light/12 hour dark

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLEAqua pro iniectioneBatch No.: 1503130162Expiration: 03/2017Producer: Ardeapharma Ševětín, Czech RepublicDOSINGThe test substance was administered to the stomach by tube. The single volume of administered suspension was 1 mL/100 g of animal body weight. The starting dose was 300 mg/kg of body weight.PREPARATION AND APPLICATION OF THE TEST SUBSTANCEImmediately before application the test substance was weighed and mixed in vehicle. The test substance was administered dissolved in water for injections.

Doses:

300 mg/kg (first step)2000 mg/kg (second step)2000 mg/kg (confirmation)

No. of animals per sex per dose:

3 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days- Frequency of observations and weighing: 1st day: twice (30 minutes and 3 hours after application), 2nd day: twice (in the morning and in the afternoon), thereafter days: once a day- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross macroscopic changes of organs and tissues were recorded on special data sheets.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death of animals.

Clinical signs:

other: No clinical signs of intoxication were detected during whole study.

Gross pathology:

No pathologic macroscopic changes were diagnosed during pathological examination.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the study results the value of LD50 of the test substance, Direct Black 51, for female rats is higher than 2000 mg/kg of body weight.

Executive summary:

The aim of the study was to investigate acute toxic effects of the test substance, Direct Black 51 after a single oral administration to Wistar Han rats. The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test substance was administered dissolved in water for injections as a single dose, given orally via gavage to three groups of three female rats. The dosing was performed sequentially in three groups of three females: group No. 1 - first step using the starting dose of 300 mg/kg of body weight, group No. 2 - second step using higher dose 2000 mg/kg and group No. 3 – third step using the same dose 2000 mg/kg.

The test substance administered at the dose of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were detected during whole study. No pathologic macroscopic changes were diagnosed during pathological examination.

According to the study results the value of LD50 of the test substance, Direct Black 51, for female rats is higher than 2000 mg/kg of body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Determined acute oral toxicity, LD50 > 2000 mg/kg, does not meet the classification criteria specified in Regulation (EC) No. 1272/2008. Acute toxicity studies via dermal or inhalation exposure are not available.