Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[2-(4-aminophenyl)diazenyl]-3-methylbenzenamine and methanol sodium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

In an acute oral toxicity study the test substance was administered to Tif: RAIf rats (5/sex/dose) by oral gavage (3170, 4640 and 6000 mg/kg), followed by a 14 day observation period. The test substance was suspended with polyethylene glycol (PEG400). Physical condition and rate of deaths were monitored throughout the whole observation period. At the end of the observation period animals were submitted at random to a necropsy.

GLP compliance:

not specified

Remarks:

prior to GLP implementation

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(3Z)-4,5,6,7-tetrachloro-3-({3-methyl-4-[(1E)-2-(3-methylphenyl)diazen-1-yl]phenyl}imino)-2,3-dihydro-1H-isoindol-1-one; 4,5,6,7-tetrachloro-3-({3-methyl-4-[(1E)-2-{4-[(4,5,6,7-tetrachloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]phenyl}amino)-1H-isoindol-1-one; 6-acetyl-3-({4-[(1E)-2-{4-[(6-acetyl-4,5,7-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,7-trichloro-1H-isoindol-1-one; 6-acetyl-3-({4-[(1E)-2-{4-[(7-acetyl-4,5,6-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,7-trichloro-1H-isoindol-1-one; 7-acetyl-3-({4-[(1E)-2-{4-[(6-acetyl-4,5,7-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,6-trichloro-1H-isoindol-1-one; 7-acetyl-3-({4-[(1E)-2-{4-[(7-acetyl-4,5,6-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,6-trichloro-1H-isoindol-1-one; N-{4-[(1E)-2-(2-methyl-4-{[(1Z)-4,5,6,7-tetrachloro-3-oxo-2,3-dihydro-1H-isoindol-1-ylidene]amino}phenyl)diazen-1-yl]phenyl}acetamide

EC Number:

600-734-7

Cas Number:

106276-78-2

Molecular formula:

C13H14N.C9H3Cl4NO2.CH4O.Na

IUPAC Name:

(3Z)-4,5,6,7-tetrachloro-3-({3-methyl-4-[(1E)-2-(3-methylphenyl)diazen-1-yl]phenyl}imino)-2,3-dihydro-1H-isoindol-1-one; 4,5,6,7-tetrachloro-3-({3-methyl-4-[(1E)-2-{4-[(4,5,6,7-tetrachloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]phenyl}amino)-1H-isoindol-1-one; 6-acetyl-3-({4-[(1E)-2-{4-[(6-acetyl-4,5,7-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,7-trichloro-1H-isoindol-1-one; 6-acetyl-3-({4-[(1E)-2-{4-[(7-acetyl-4,5,6-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,7-trichloro-1H-isoindol-1-one; 7-acetyl-3-({4-[(1E)-2-{4-[(6-acetyl-4,5,7-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,6-trichloro-1H-isoindol-1-one; 7-acetyl-3-({4-[(1E)-2-{4-[(7-acetyl-4,5,6-trichloro-1-oxo-1H-isoindol-3-yl)amino]phenyl}diazen-1-yl]-3-methylphenyl}amino)-4,5,6-trichloro-1H-isoindol-1-one; N-{4-[(1E)-2-(2-methyl-4-{[(1Z)-4,5,6,7-tetrachloro-3-oxo-2,3-dihydro-1H-isoindol-1-ylidene]amino}phenyl)diazen-1-yl]phenyl}acetamide

Test material form:

solid: nanoform

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: raised on the premises
- Weight at study initiation: 160 - 180 g
- Fasting period before study: Animals fasted overnight
- Housing: During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3)
- Diet: rat food, NAFAG, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

DOSAGE PREPARATION:
The test substance was suspended with polyethylene glycol (PEG 400) Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Concentration (%) of formulation: 30 %

Doses:

3170, 4640 and 6000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Physical condition and rate of deaths were monitored throughout the whole observation period.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 000 mg/kg bw

Mortality:

No mortality was observed.

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The animals recovered within 8 to 12 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 acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 6000mg/kg. The test material has therefore practically no acute toxicity to the rat by this route of administration.

Executive summary:

A study similar to OECD Guideline 401 was performed. The acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 6000mg/kg. The test material has therefore practically no acute toxicity to the rat by this route of administration.