Violanthrene-5,10-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Violanthrene-5,10-dione

EC Number:

204-152-0

EC Name:

Violanthrene-5,10-dione

Cas Number:

116-71-2

Molecular formula:

C34H16O2

IUPAC Name:

violanthrene-5,10-dione

Test material form:

solid: particulate/powder

Details on test material:

Vat Blue 20

Test animals

Species:

rat

Strain:

other: Tif RAIf strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

Healthy random bred rats of the Tif RAI f strain raised on our 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 14 hours light cycle day. They received ad libitum a standard diet of pellets - No. 890, Nafag Gossau SG - and water. Prior to treatment the rats were acclimatized to our laboratories for a minimum of 5 days. The mean initial body weight of the groups ranged from 90 to 100 grams.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10%, 25%, 30%
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: test item is neither soluble in water nor in organic solvents, thus water as vehicle for the suspension was chosen


DOSAGE PREPARATION (if unusual): suspension

Doses:

Nominal concentrations: 1000/3000/10000/15000 mg/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: pre-test day and on day 15 of test
- Necropsy of survivors performed: yes, autopsies were performed on those that died and on surivor at day 15 of the study.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks:

59% active ingrediend = 8850 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 000 - < 15 000 mg/kg bw

Based on:

test mat.

Remarks:

59% ai

Mortality:

- At 1000 mg/kg: no deaths
- At 3000 mg/kg: no deaths
- At 10000 mg/kg: no deaths
- At 15000 mg/kg: 3/5 females and 0/5 male died

Clinical signs:

- At 1000 mg/kg: no effects
- At 3000 mg/kg: reduction in spontaneous motility and ataxia lasting >6 hours. After 24 hours no symptoms
- At 10000 mg/kg: reduction in spontaneous motility and ataxia lasting >6 hours. After 24 hours no symptoms
- At 15000 mg/kg: eduction in spontaneous motility and ataxia lasting >6 hours, muscular hypotonia, diarrhea, roughening of the coat. After 7 days no symptoms

Body weight:

Expected body weight gain was observed

Gross pathology:

no effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of Vat Blue 20 was > 15000 mg/kg bw in male rats and between 10000 15000 mg/kg bw in female rats.

Executive summary:

A study was performed to determine the acute oral toxicity of Vat Blue 20 on rats via oral route. Physical condition and rate of deaths were monitored throughout the whole observation period. A doses of 1000, 3000, 10000 and 15000 mg/kg bw was given by oral gavage.

Clinical signs were observed at dose levels of 3000 mg/kg bw and above. No males rats died, three female rats died at the highest dose level.

Thus, the acute oral LD50 of Vat Blue 20 was > 15000 mg/kg bw in male rats and between 10000 15000 mg/kg bw in female rats.