3,3'-[(2,5-dimethyl-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:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Quality Assurance Unit supervision

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

226-107-4

EC Name:

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

Cas Number:

5280-80-8

Molecular formula:

C44H38Cl4N8O6

IUPAC Name:

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

Test material form:

solid: particulate/powder

Details on test material:

Lot no. 057249.28
Test item stability garantueed by sponsor
Test material received April 18, 1983
- Storage: Room temperature

Specific details on test material used for the study:

commercial grade

Test animals

Species:

rat

Strain:

other: Tif : RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Ltd. Tierfarm, Sisseln / Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 177 - 217 g
- Fasting period before study: overnight
- Housing: in groups of five
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau / Switzerland; ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 55 +/- 15%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

(PEG 400)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 mg/kg bw

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: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and Symptoms: daily; Body weight: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalities observed.

Mortality:

No mortalities observed.

Clinical signs:

other: Dyspnoea (day 1 - day 10), exophthalmus (day1 - day 9), ruffled fur (day 1 - day 7), diarrhea (day 1) and curved body position (day 1 - day 5) were observed, being common symptoms in acute tests. In addition a transient sedation was noted. The surviving a

Gross pathology:

Besides some enlarged caeca (in 4 male and 2 female animals), no noticeable findings were made at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the test conditions the test substance has practically no acute toxicity when adminstered orally to the albino rat.

Executive summary:

In an acute oral toxicity study (BAF, 1983), groups of 5 male and 5 female Wistar rats were given a single oral dose of the test substance in polyethylene glycol at a dose of 5000  mg/kg bw and observed for 14 days. No animals died and the treated animals did showed common symptoms as dyspnoea, exophtalmus, ruffled fur and curved body position. In addition a transient sedation was noted. Therefore the LD50 is greater than 5000 mg/kg bw. In conclusion, according to the test conditions the test substance has practically no acute toxicity when adminstered orally to the albino rat.