Sodium 4-amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)naphthalene-2,7-disulphonate

Endpoint summary

Description of key information

Acute oral toxicity:

LD50 = 5000 mg/kg body weight

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:

March 2, 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to a method similiar to internationally accepted testing guidelines.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

mouse

Strain:

CF-1

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult mice
-Mean body weight at study initiation: c.a 23 g
- Diet (e.g. ad libitum): Altromin No.1324 DK pellets
- Water : fresh water ad libitum
- Food deprivation: test substance was applied after food deprivation of 18 h.
- Acclimation period: the animales were acclimatized in test cage 5 days prior to application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature was approx 22 °C
- Humidity (%): c.a. 50 %
- Photoperiod (hrs dark / hrs light): artificial lighting of the room varied every 12 hours

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: the product was provided as pure substance

- Purity:

MAXIMUM DOSE VOLUME APPLIED:
- Injectin volume: constant 20 cm3/kg

Doses:

Single dose application : 5,000 mg/kg

No. of animals per sex per dose:

Ten mice were used

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, withou any significant results
Other examinations performed:
- clinical signs n ot appliacble.
- Body weight: before application mean of 23.05

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animale died during the test duration

Clinical signs:

other: Not applicable

Gross pathology:

Without any significant finding

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

LD 50 >5000 mg/kg body weight

Executive summary:

Method:

Acute oral toxcicity was determined by a single oral appication via stomach tube in male mice, according to the a guideline similar to OECD 423.

Observation:

There were no symptoms of intoxication.

Results:

An LD50 value of > 5000 mg/kg body weight was found.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

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

Acute oral toxcicity for Acid Black 001 was determined by a single oral appication via stomach tube in male mice, according to the a guideline similar to OECD 423. There were no symptoms of intoxication. An LD50 value of > 5000 mg/kg body weight was found.

Anotehr test used as supporting study shows an LD50 = 13913 mg/kg body weight.

Justification for classification or non-classification

Oral acute toxicity According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:

Oral (mg/kg bodyweight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The acute oral median lethal dose LD50 in mice is > 5000 mg/kg body weight. The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.

Inhalation acute toxicity: No data avilable

Dermal acute toxicity: No data available