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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 study. Test item is a formulation with < 80% active ingredient.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(limit dose tested 2500 mg/kg bw, documentation limitations with respected to test animals and animal welfare)

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

Details on test material:

- Analytical purity: a solid formulation containing approx. 42% of the dye (100% pure)

Specific details on test material used for the study:

solid blend of the test substance with other ingredients.
Content of the test substance: 42%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga
- Mean weight at study initiation: 145 g (male) and 131 g (female)
no further data available

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm²
- % coverage: at least 10% of body surface

TEST MATERIAL
- Amount(s) applied: 0.6 - 0.8 g/animal (5 mL / kg bw corresponds to 2.5 mg/kg bw)
- Concentration (if solution): 50%
- Paste formed: yes

REMOVAL OF TEST SUBSTANCE
- Washing: no

Duration of exposure:

24 h

Doses:

1050 mg/kg bw (a.i.)

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: upon removal of test patch, then at least once daily
- Frequency of weighing: before treatment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Determination of the median lethal dose or LD50 calculated according to LITCHFIELD-WILCOXON

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 1 050 mg/kg bw

Based on:

other: formulation containing 42% of the test substance

Remarks on result:

other: 0 of 10 animals died

Mortality:

0/10

Clinical signs:

other: no abnormalities detected

Gross pathology:

no abnormalities detected

Other findings:

Local irritation of skin: no
Upon removal of the test patches, light blue substance rests were present on the application site. This was no longer seen 4 days later.