6,15-dihydroanthrazine-5,9,14,18-tetrone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline with acceptable restrictions - no GLP - reduced documentation

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6,15-dihydroanthrazine-5,9,14,18-tetrone

EC Number:

201-375-5

EC Name:

6,15-dihydroanthrazine-5,9,14,18-tetrone

Cas Number:

81-77-6

Molecular formula:

C28H14N2O4

IUPAC Name:

6,15-dihydroanthrazine-5,9,14,18-tetrone

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: solid
- Analytical purity: a formulation containing approx. 87% of the dye (100% pure)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Mean weight at study initiation: 150g (female) and 200 g (male)
- Fasting period before study: 15 h- 20 h before administration


ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

(0.5%)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw.

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: <15 min - 5h, 1 d, 4 d, 5 - 8 d, 11 - 14 d after administration
- Frequency of weighing: at the beginning, and then after 4 d, 7 d and 13 d after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other: Faeces coloured blue 24 hours after application of the test substance. This effect was no longer evident from 48 hours till end of the observation period. The animals were all in a good general condition.

Gross pathology:

No abnormalities detected.

Other findings:

A preliminary test was performed with 1000 and ca. 5000 mg/kg bw using 2 female rats/dose. None of the animals died. No clinical sign of toxicity was reported. No abnormality was seen at gross necropsy.

Any other information on results incl. tables

Table 1: Mean weight (g)

		5000 mg/kg bw
Male animals	At beginning	200
	After 4 days	196
	After 7days	186.4
	After 14 days	235
Female animals	At beginning	150
	After 4 days	178
	After 7days	186.8
	After 14 days	192.6