2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12Dec1978 to 24Jan1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Study was conducted in 1978-1979, no test guideline was available.

GLP compliance:

not specified

Remarks:

Study was conducted in 1978-1979, facility was not noted to be GLP compliant. (although a study director was appointed and arhiving of test data was undertaken)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride

EC Number:

278-601-4

EC Name:

2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride

Cas Number:

77061-58-6

Molecular formula:

C13H18N5.Cl

IUPAC Name:

2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Test Material Name: FAT 31063/B
Test material received: November 10, 1978
Batch No.: EN 13465.76
Physical appearance: solid

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

Healthy random bred rats of the Tif: RAIf (SPF) strain (7 to 8 weeks old) raised on the premises were used for these experiments. They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days.

Administration / exposure

Route of administration:

other: oral intubation

Vehicle:

polyethylene glycol

Remarks:

polyethylene glycol (PEG 400)

Details on oral exposure:

FAT 31063/B was suspended. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Animals fasted overnight were treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.

No. of animals per sex per dose:

5 animals per sex per dose.

Control animals:

no

Statistics:

LD 50 including 95 % confidence limits were calculated by the logit model.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 020 mg/kg bw

Based on:

test mat.

95% CL:

>= 696 - <= 1 529

Mortality:

See table 1 for death rate per group.

Clinical signs:

See tables 3,4,5,6 & 7 for clinial signs

Body weight:

See table 1 for bodyweight changes

Gross pathology:

Autopsies:
Dead and killed Animals: No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 of Basic Red 51 in rats of both sexes observed over a period of 14 days is 1020 (696-1529) mg/kg. Based on EC 1272/2008 and utilising the oral LD50 of 1020 mgkg, Basic Red 51 should be classified as Acute Oral Toxicitiy Category 4 (H302).

Executive summary:

The acute oral LD50 of Basic Red 51 in rats of both sexes observed over a period of 14 days is 1020 (696-1529) mg/kg. Based on EC 1272/2008 and utilising the oral LD50 of 1020 mgkg, Basic Red 51 should be classified as Acute Oral Toxicitiy Category 4 (H302).