3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (no data on test substance purity).

Justification for type of information:

Category approach as part of CSR.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

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

1

Reference substance name:

3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]

EC Number:

226-970-7

EC Name:

3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]

Cas Number:

5580-57-4

Molecular formula:

C43H35Cl5N8O6

IUPAC Name:

3,3'-{(2-chloro-5-methyl-1,4-phenylene)bis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}bis[4-chloro-N-(3-chloro-2-methylphenyl)benzamide]

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rat

Strain:

other: Tif : RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breed
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: mean(males): 185 g; mean(females): 168 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet: Rat food - NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 14 / 10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

(PAG 400)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw (2000 mg/kg) or 20 mL/kg bw (3000 or 4000 mg/kg bw)

DOSAGE PREPARATION (if unusual):The test substance was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

2000, 3000, 4000 mg/kg bw (No higher doses were possible).

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days. Physical condition and rate of deaths were monitored throughout the whole observation period.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality; unspecific clinical signs observed

Mortality:

No mortality observed.

Clinical signs:

other: Sedation, dyspnoea, exophthalmos, ruffled fur, curved body position and diarrhoea were observed. The animals recovered within 6 to 9 days.

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information