3-[[9,10-dihydro-9,10-dioxo-4-[(p-tolyl)amino]-1-anthryl]aminopropyl]trimethylammonium methyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Oct 1974

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:

1974

Report date:

1974

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:

Male rats were administered the test substance by oral gavage. The application was followed by a 14-d observation period and thereafter the animals were sacrificed.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-[[9,10-dihydro-9,10-dioxo-4-[(p-tolyl)amino]-1-anthryl]aminopropyl]trimethylammonium methyl sulphate

EC Number:

276-896-4

EC Name:

3-[[9,10-dihydro-9,10-dioxo-4-[(p-tolyl)amino]-1-anthryl]aminopropyl]trimethylammonium methyl sulphate

Cas Number:

72828-93-4

Molecular formula:

C27H30N3O2.CH3O4S C28H33N3O6S

IUPAC Name:

trimethyl[3-({4-[(4-methylphenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)propyl]azanium methyl sulfate

Test material form:

solid

Details on test material:

Basic Blue 45 MeSO4

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Breeder: Winkelmann, Borchen
Age: ca. 8 weeks old
Body weight: 150-200 g
Temperature and relative humidity: 22 +/- 1.5°C and 60 +/- 5%, respectively
Light period: 12 h light - 12 h dark
Feed: Altromin R 1324

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Dose volume applied: 20 mL/kg bw

Doses:

3000, 3500, 4000, 4500, 5000, 6300 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Statistics:

Probit analysis

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

4 068 mg/kg bw

Based on:

test mat.

95% CL:

> 3 735 - < 4 418

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2 115 mg/kg bw

Based on:

act. ingr.

Mortality:

0/10 at 3000 mg/kg bw, 3/10 at 3500 mg/kg bw, 5/10 at 4000 mg/kg bw, 7/10 at 4500 mg/kg bw, 8/10 at 5000 mg/kg bw, 10/10 at 6300 mg/kg bw

Clinical signs:

Sedation, breathing difficulties, seizures

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). The substance is not classifiable according to CLP criteria.