m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)

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:

1980

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:

The test substance was administered to rats (once by gavage) in doses of 5000, 6000, 7000 and 8000 mg/kg bw (5 per sex per dose) and the rats were followed for 14 days. The animals were observed for mortality, body weight, and clinical signs. In addition gross necropsy was performed.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)

EC Number:

279-213-8

EC Name:

m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)

Cas Number:

79665-26-2

Molecular formula:

C32 H30 N2 O8 S2 . C6 H16 N2

IUPAC Name:

m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Tif:RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7-8 weeks
- Weight at study initiation: Males: mean dose group weights between 190 - 221g; Females: mean dose group weights between 165 - 179g
- Housing: In groups of 5 in Macrolon cages (type 3)
- Diet: ad libitum rat food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: minimal 4 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle: 20 ml/kg body weight

Doses:

5000, 6000, 7000, 80000 mg/kg body weight

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: 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

Statistics:

LD50 including 95% confidence limits are calculated by the logit model.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: - 5000 & 7000 mg/kg bw: Slight dyspnoea, up to day 7; Slight exophthalmos, up to day 8; Slight ruffled fur, up to day 7 (moderate in hours 3 and 5 of the first day); Slight diarrhoea up to the first 3 hours, moderate diarrhoea in the fifth hour of the fir

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

The animals recovered within 9 days.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met