Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Endpoint summary

Description of key information

acute oral toxicity, rat (M/f), gavage, > 8000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

performed on analogue substance

Qualifier:

according to guideline

Guideline:

other: acute toxicity procedure not further specified

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

other: Tif:RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female rats (7 to 8 weeks old) raised on the premises were used for these experiments.. They were kept at a room temperature of 22 +/- 2° C, at a relative humidity of 55 +/- 10 % and on a 10 hours light cycle day. They received ad libitum rat food -NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to the laboratories for a minimum of 4 days. Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picricacid.

Route of administration:

oral: gavage

Details on oral exposure:

Animals were fasted overnight and gavaged once

Doses:

4000,5000,6000 and 8000 mg/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 6 000 - < 8 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was observed on 2 females at the highest dose after 24h

Clinical signs:

other: Slght dispnea, exoftalmosis, ruffled fur, diarrohea, hunched position were observed that however stopped at day 8 of observation period for the 4000, 5000, 6000 mg/kg. At 8000 mg/kg the effects were stronger and sedation appeared, however these effects st

Gross pathology:

No substance related gross organ changes were seen.

Interpretation of results:

other: not classified, Regulation 1272/2008

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test item was tested for acute toxicity following internal guidelines. Under the experimental conditions the LD50 > 8000 mg/kg.

Executive summary:

The test item was tested for acute toxicity. Groups of five males and five females were gavaged once at 4000, 5000, 6000 and 8000 mg/kg and observed for 14 days for death, clinical signs and gross patology. Under the experimental conditions the LD50 > 8000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

8 000 mg/kg bw

Additional information

The analogue test item was tested for acute oral toxicity (Huntsman, 1980). Male and female rats were gavaged at different doses up to 8000 mg/kg bw. Under the experimental conditions the LD50 > 8000 mg/kg bw.

Based on the read across considerations the same results apply to target substance

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 8000 mg/kg bw , which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.