14H-benz[4,5]isoquino[2,1-a]perimidin-14-one

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:

other: short report, in compliance with the guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Five male and five female Wistar rats were given 5000 mg MACROLEX Red CA 51038 (CAS no 6829-22-7)/kg bw dissolved in lutrol and observed for mortality and clinical signs and body weight development over a period of 14 days. Gross pathological examinations were done on all animals sacrificed at the end of study.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

14H-benz[4,5]isoquino[2,1-a]perimidin-14-one

EC Number:

229-904-5

EC Name:

14H-benz[4,5]isoquino[2,1-a]perimidin-14-one

Cas Number:

6829-22-7

Molecular formula:

C22H12N2O

IUPAC Name:

14H-benz[4,5]isoquino[2,1-a]perimidin-14-one

Test material form:

other: red powder

Details on test material:

no further data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males 9 weeks; females 14 weeks
- Weight at study initiation: males ca 158 g; females ca 164 g
- Fasting period before study: 16 hours
- Housing: in groups of 5 per sex
- Diet : fasting post administration for 4 hours then ad libitum
- Water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

Single oral application by gavage of 5000 mg/kg bw to male and female rats

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of administration and then twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological evaluation

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test: no animal died, no clinical signs, growth not retarded

Mortality:

no rat died

Clinical signs:

other: no clinical signs were observed

Gross pathology:

no gross pathological findings

Any other information on results incl. tables

After single administration of 5000 mg/kg no clinical signs of systemic poisoning were observed.

No deaths occurred.

The male and female rats sacrificed at the end of the study did not show any noticeable gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No animal died. Thus the LD50 is greater than 5000 mg/kg bw/day.

Executive summary:

In a study according to the respective guideline 5 male and 5 female Wistar rats were given 5000 mg MACROLEX Red CA 51038 (CAS no 6829-22-7)/kg bw dissolved in lutrol and observed for mortality and clinical signs and body weight development over a period of 14 days. No animal died or displayed clinical signs. Necropsy revealed no gross pathological changes. Thus the LD50 is considered to be greater than 5000 mg/kg bw/day.