Reaction Mass of disodium [(E)-7-nitro-3-oxido-4-((2-oxidonaphthalen-1-yl)diazenyl)naphthalene-1-sulfonate) (E)-1-((3,5-dinitro-2-oxidophenyl)diazenyl)naphthalen-2-olate) chromate(2-)] and Hydrogen [(E)-7-nitro-3-oxido-4-((2-oxidonaphthalen-1-yl)diazenyl)naphthalene-1-sulfonate)(E)-1-((3,5-dinitro-2-oxidophenyl)diazenyl)naphthalen-2-olate) chromate(2-)]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: acute toxicity procedure not further specified

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

1

Reference substance name:

not applicable being a mixture

IUPAC Name:

not applicable being a mixture

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Black powderwater solubility: 40g/lstorage: room temperatureexpiration date: March 2003

Test animals

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.

Administration / exposure

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

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Based on:

test mat.

Effect levels 2

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.

Applicant's summary and conclusion

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. 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.