Tetrasodium 4-[[3,5-bis[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]-2,4(or 2,6)-dihydroxyphenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate

Endpoint summary

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Qualifier:

according to guideline

Guideline:

other: Real Decree 363/1995 and Real Decree 1078/93

Principles of method if other than guideline:

Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation

GLP compliance:

no

Remarks:

Centre certificated ISO 9001 by National Accreditation Program (N. 98-1101)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: authorized provider.
- Health: rats were submitted to a sanitary control.
- Age at study initiation: young and healthy rats
- Housing: 3 rats for every cube of Makrolon (48 x 27 x 20 cm) by Tecniplast, with bed of woodchip. Each cube has been signed by label.
- Diet: free access to specific fodder for experimental rat, supplied by authorized provider
- Water: tap water ad libitum by Makrolon bottle
- Acclimatation period: 7 days

Before starting test each rat was marked by black pen on tail

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 25
- Air changes (per hr): 15 air changes by pre-filtration of 5 µm
- Photoperiod (hrs dark / hrs light): 12/12 by timer

OTHER
Materials used:
Balance: COBOS D 6000-SX
Vinyl/latex Gloves
Syringes of 1 and 2 ml

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

PREPARATION/ADMINISTRATION OF TEST SUBSTANCE:
2000 mg of test substance were dissolved in 20 ml of water.
Administration: 2 ml/100 g of body weight. Forced administration by metallic cannula, after a fasting night.
Since 3 hours after administration, the regular diet was recovered

Doses:

25, 200 and 2000 mg/Kg bw

No. of animals per sex per dose:

3 per 3 per dose

Control animals:

not specified

Details on study design:

- Administration: oral administration by metallic probe
- Duration of observation period following administration: 14 days
- Frequency of observations: In the first day frequent observations, and then, once every working day
- Sacrifice: yes by CO2 inhalation or cervical dislocation
- Necropsy performed: yes, macroscopic
- Body weight: performed at the start of the study, before substance administration, at 7 days after administration and at the end of the study.
- General examination: skin, fur, eyes, mucose, respiratory system, cardiovasculary system, central and periheral nervous system, somatomotor system and behaviour. A particular attention was given to tremors, convulsions, salivation, diarrhea, letargia, sleep and coma.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality at 2000 mg/Kg bw was observed.

Clinical signs:

other: No abnormalities were observed during the test period

Gross pathology:

No abnormalities were observed

Other findings:

No abnormalities were observed

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 oral rat > 2000 mg/Kg bw.

Executive summary:

The susbtance was tested for oral acute toxicity according to the Real Decree 363/1995, that is the transposition of Directive 67/548/EEC in Spanish legislation. The LD50 value is > 2000 mg/kg.

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

Additional information

Based on the test result for acute oral toxicity, the tested substance is considered as not toxic for oral route with a LD50 > 2000 mg/kg.

Justification for selection of acute toxicity – oral endpoint
Test well reported

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be greater than 2000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.