4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bisarenoate sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

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:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): FAT 66031/A
- Analytical purity: > 80%
- Physical state: solid
- Lot/batch No.: Op. 1/81

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
- Body weights at study initiation: males - 175 g; females - 176 g
- Fasting period before study; overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet: rat food NAFAG No. 890 NAFAG Gossau SG; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg body weight

Doses:

5000 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 and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights

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

Mortality:

No mortality occurred.

Clinical signs:

Dyspnoea reported at 1, 2, 3, 5, 24 hours and on days 2, 3, 4, 5, 6, 7, and 8.
Exophthalmos reported at 1, 2, 3, 5, 24 hours and on days 2, and 3
Ruffled fur reported at 1, 2, 3, 5, 24 hours and on days 2, 3, 4, 5, 6, and 7
Diarrhoea reported at 2 and 3 hours after dosing
Curved body position reported at 1, 2, 3, 5, 24 hours and on days 2, 3, 4, 5, and 6

Body weight:

Body weights and body weight gains were in the normal range.

Gross pathology:

No compound-related findings were reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of the test substance in rats of both sexes observed over a period of 14 days is > 5000 mg/kg body weight.