Tetrasodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-4-hydroxy-3-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalene-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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Justification for type of information:

Justification for read across is detailed in the report attached to the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

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:

No abnormalities were observed during the test period

Body weight:

Normal body weight variation

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

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Justification for read across is detailed in the report attached to the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

no guideline available

Principles of method if other than guideline:

The study report contains the limited information on the test conditions because the study has been performed in 1990. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 235 - 275 g

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg
- For solids, paste formed: yes

Doses:

5 g/kg

No. of animals per sex per dose:

5 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died.

Clinical signs:

Without any clinical signs of intoxication.

Gross pathology:

No macroscopically observable changes were detected in the organs.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 5000 mg/kg bw
Not classified according to GHS criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

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

For acute dermal toxicity:

Category 1: 0 < ATE <= 50 mg/kg bw

Category 2: 50 < ATE <= 200 mg/kg bw

Category 3: 200 < ATE <= 1000 mg/kg bw

Category 4: 1000 < ATE <= 2000 mg/kg bw

Based on the test result, the substance is to be considered as not toxic for acute oral and dermal exposure.