Bisbenzimidazobenzo[lmn][3,8]phenanthrolinedione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study meets requirements of OECD Guideline 401, 84/449/EEC, B.1 without deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bisbenzimidazobenzo[lmn][3,8]phenanthrolinedione

EC Number:

232-340-2

EC Name:

Bisbenzimidazobenzo[lmn][3,8]phenanthrolinedione

Cas Number:

8005-56-9

Molecular formula:

C26H12N4O2

IUPAC Name:

bisbenzimidazobenzo[lmn][3,8]phenanthrolinedione

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, Kastengrund, SPF-breed
- Age at study initiation: 7 weeks (male), 8 weeks (female)
- Weight at study initiation: male 170 g - 183 g (mean 177 g), female 160 g - 175 g (mean 167 g)
- Fasting period before study: approximately 16 hours before until 3-4 hours after treatment, access to water permitted
- Housing: in groups of five in Makrolon type 4 cages with standard softwood bedding
- Diet (e.g. ad libitum): standard rat diet (Altromin 1324) ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles ad litidum
- Acclimation period: not necessary (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20.0 % suspension; the test item was suspended in sesame oil and distributed homogeneously by means of a magnetic stirrer. Stability and homogeneity of the test substance was determined by analytical methods and guaranteed for 4 hours.
- Amount of vehicle (if gavage): 10 mL/kg body weight (test item in vehicle administered)
- Purity: Oleum Sesami Ph. Eur. III

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days starting with treatment day 1
- Frequency of observations and weighing:
- symptoms were recorded twice daily, on weekends and holidays only once.
- body weights: on days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occured during the whole study

Clinical signs:

other: no symptoms were observed after application of 2000 mg/kg bw. One day p.a. the feces of the animals were discoloured red.

Gross pathology:

No macroscopic findings at scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

The test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008

Conclusions:

The test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.

Executive summary:

One group of five male HoeWISK (SPF71) rats and one group of five female HoeWISK (SPF71) rats were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended in vehicle (sesame oil) at a concentration of 0.2 g/mL and administered at a volume dosage of 10 mL/kg.

The animals were examined for mortality and clinical signs twice daily (once at weekends and holidays) during test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

After application of 2000 mg/kg b.w. neither deaths nor symptoms occurred leading to an LD50 above 2000 mg/kg bw.

One day after application the feces of the animals was discoloured red.

Development of body weight was not impaired.

The animals killed at the end of the observation period showed no macroscopically visible changes

Based on that findings, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.