2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

April 1977

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 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Five male and five female mice were treated with a single intraperitoneal dose of test material at a dose level of 2000 mg/kg followed by a 14 day observation period.

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

EC Number:

226-866-1

EC Name:

2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

Cas Number:

5521-31-3

Molecular formula:

C26H14N2O4

IUPAC Name:

2,9-dimethylisoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone

Details on test material:

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (U.K.) Ltd., Manston Road, Margate, Kent
- Weight at study initiation: on the day before dosing individual body weights were in the range 17 - 24 g.
- Fasting period before study: overnight fast (for 18 - 20 hours before treatment)
- Housing: solid floor boxes furnished with sterilised sawdust, in groups of 5
- Diet (e.g. ad libitum): Rat and Mause No. 1 Expanded Diet (B.P. Nutrition (U.K.) Ltd., Stepfield, Witham, Essex), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for a minimum of 3 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 10
- Air changes (per hr): animais were housed in a single air-conditioned room
- Photoperiod (hrs dark / hrs light): natural lighting conditions

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animais were observed for overt toxicity and mortality at 15 minutes and 1, 2 and 4 hours after treatment and subsequently once daily for 14 days and the observations were recorded. Body weights of survivors were recorded 14 days after treatment.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: mortality was observed

Mortality:

Two female mice died within 24 hours of treatment.

Clinical signs:

No signs of overt toxicity were apparent during the 14 day observation period.

Body weight:

All surviving animals showed normal body weight gains throughout the observation period.

Applicant's summary and conclusion

Conclusions:

The test substance was investigated for its acute toxic potential. Two out of five animals died within 24 h of treatment. The LD50 was concluded to be greater than 2000 mg/kg bw.