14H-anthra[2,1,9-mna]thioxanthen-14-one

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1970

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: no GLP; no data on test sample; early study not according to current guideline, but including basic scientific standards of performance and reporting;

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

yes

Remarks:

limited range of laboratory investigations; No FOB

GLP compliance:

no

Remarks:

predates GLP regulation

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fluoreszenzrot GG

IUPAC Name:

Fluoreszenzrot GG

Details on test material:

red powder
technically pure

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: no data
- Weight at study initiation:m: 141g (110-167); f: 119 (98 - 134)
- Fasting period before study: no
- Housing: groups of 5
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 35 -65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1969-09-17 To: 1969-10-17

Administration / exposure

Route of administration:

oral: feed

Vehicle:

not specified

Details on oral exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency): no data
- Mixing appropriate amounts with (Type of food): Altromin

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

30 days

Frequency of treatment:

continuous

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0 %
Basis:
nominal in diet

Doses / concentrations 2

Remarks:

Doses / Concentrations:
1 %
Basis:
nominal in diet

Doses / concentrations 3

Remarks:

Doses / Concentrations:
5%
Basis:
nominal in diet

No. of animals per sex per dose:

10

Control animals:

yes, plain diet

Details on study design:

- Dose selection rationale: As the testmaterial was not toxic in an acute test the highest standard dose of 5% in diet was chosen
- Rationale for animal assignment (if not random): at random

- Post-exposure recovery period: all animals : 4-7 d
- Section schedule rationale (if not random): no data

Positive control:

no

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
- Fodd consumption measured on a weekly basis

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: before and at the end of treatment period
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all
- Parameters were examined: Numbers of red cells, white cells, differntial white cell count; hemoglobin content

CLINICAL CHEMISTRY: No data

URINALYSIS: Yes
- Time schedule for collection of urine: before and at the end of treatment period
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked : Protein, no further data

NEUROBEHAVIOURAL EXAMINATION: No data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (heart, spleen, adrenals, kidneys, lungs, liver)

Statistics:

no data

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

not examined

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Effect levels

Dose descriptor:

NOAEL

Effect level:

>= 50 000 mg/kg diet

Based on:

test mat.

Remarks:

nominal in diet

Sex:

male/female

Basis for effect level:

other: overall effects

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The treatment of rats for 30 days via diet with the testmaterial did not induce any adverse effects.

Executive summary:

Wistar-K rats were treated for 30 days via diet at concentrations of 1 and 5 % (w/w) with the testmaterial. Clinical signs, body weights, blood as well as urine were examined on a regular basis. Four to 7 days after the end of treatment all anmals were killed and examined macroscopically. Hearts, livers, lungs, kidneys, spleen and adrenal glands were investigated microscopically.

No test substance related adverse effects were detected.

The NOAEL was 50000 ppm in diet (nominal) which corresponds to about 900 mg/kg bw/day.