Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with p-phenylenediamine and sodium methoxide

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

unknown concentration in vehicle, uncommon dose selection, high dose volume in PEG

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]

EC Number:

226-999-5

EC Name:

3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]

Cas Number:

5590-18-1

Molecular formula:

C22H6Cl8N4O2

IUPAC Name:

3,3'-(1,4-phenylenediimino)bis(4,5,6,7-tetrachloro-1H-isoindol-1-one)

Constituent 2

Reference substance name:

mono/bis-methoxy derivatives

Molecular formula:

C22-24H6-12Cl6-8N4O2-4

IUPAC Name:

mono/bis-methoxy derivatives

Test material form:

solid: bulk

Specific details on test material used for the study:

- Physical state: solid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: Tif: RAif (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 to 8 weeks
- Mean weight at study initiation per treatment group: males 193-208 g (maximum SD: 13.4 g); females 172-188 g (maximum SD: 9.4)
- Fasting period before study: overnight
- Housing: groups of 5 in Macrolon cages (type 3)
- Diet (e.g. ad libitum): NAFAG, Gossau SG, CH; ad lib.
- Water (e.g. ad libitum): not specified; ad lib.
- Acclimation period: at least 4 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 and 20 mL/kg bw

Doses:

2000, 3000, 4000 and 5000 mg/kg bw (5000 mg/kg bw was reported to be the highest possible dose)

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: Physical condition and rate of deaths were monitored throughout the whole observation period. Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
- Necropsy of survivors performed: yes. The animals were submitted at random to a necropsy at the end of the observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed.

Mortality:

No mortality observed.

Clinical signs:

other: Dyspnoea, exophthalmus, curved position and ruffled fur were observed in all treatment groups and were reversible within at least 8 days (2000-3000 mg treatment) or 9 days (>=4000 mg).

Gross pathology:

No substance-related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met