Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 August 1974

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1874

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)

Molecular formula:

C17H10ClCrN2Na2O10S2.C17H11ClCrN2Na3O11S2

IUPAC Name:

Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: 50 Tif. RAI rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g
- Fasting period before study: one night
- Housing: housed in Macrolon cages (Type 3) in groups of 5
- Diet: NAFAG, Gossau SG, rat food) ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

polyethylene glycol (PEG 400)

Doses:

3170, 4640, 6000, 7750 and 10000 mg/kg.

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

The LD50 was calculated by probit analysis method (Goulden A. Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

7 638 mg/kg bw

Based on:

test mat.

95% CL:

> 6 637 - < 8 790

Mortality:

No mortality was found at 3170 mg/kg dose. One animal each was died at 4640 and 6000 mg/kg dose. 6 animal at 7750 mg/kg and 8 animals at 10000 mg/kg dose.

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral median lethal dose (LD50) of FAT 20044/A is 7638 mg/kg.

Executive summary:

An acute oral toxicity study with FAT 20044/A was carried out in rats. The dose level used in the study was 3170, 4640, 6000, 7750 and 10000 mg/kg. 5 rats per sex per dose were administered with test item. There were no mortality was found at 3170 mg/kg dose. However, one animal each was died at 4640 and 6000 mg/kg dose and 6 animal died at 7750 mg/kg and 8 animals at 10000 mg/kg dose. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days. There were no substance related gross organ changes were seen. So based on the study results, oral median lethal dose (LD50) of FAT 20044/A is 7638 mg/kg.