3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ESTOFIL BLUE S-RLS; C 418

IUPAC Name:

ESTOFIL BLUE S-RLS; C 418

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf I Switzerland
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: Males: 198 - 207 g; Females: 175 - 182 g
- Fasting period before study:
- Housing: Makrolon type-3 cages in groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least one week under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 40-70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250mg/ml

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

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: observation daily, weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

No effect

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral treatment of rats with a dose of 5000 mg/kg bw did not cause any adverse effects.

Executive summary:

The test article was administered to rats of both sexes by oral gavage, at a dose of 5000 mg/kg in PEG 400 at an application volume of 20 ml/kg. Animals were observed for 15 days.

No moratlity was detected at 5000 mg/kg.

No symptoms were observed.

No macroscopic organ changes were observed in survivors at the end of the observation period.

The acute oral LD50 of the test material in rats of both sexes, observed over a period of 15 days, was estimated to be:

greater than 5000 mg/kg