Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Company guideline similar to OECD 401

Deviations:

no

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione

EC Number:

224-152-4

EC Name:

Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione

Cas Number:

4216-02-8

Molecular formula:

C26H12N4O2

IUPAC Name:

bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione

Test material form:

solid: nanoform

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, breeding colony, SPF-breed
- Weight at study initiation: female 110 g - 120 g (mean 114 g)
- Fasting period before study: approximately 16 hours before until 2 hours after treatment, access to water permitted
- Housing: in plastic cage 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 libitum
- Acclimation period: not necessary (breeding at identical conditions)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 12.5 % suspension

Doses:

15 000 mg/kg bw; 2 applications of 7 500 mg/kg bw respectively within 1 hour.

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no lethality within the 14 day observation period

Mortality:

- no deaths occurred

Clinical signs:

other: - post application faeces was stained red - diarrhea, squatting posture

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:

Single application of 15 000 mg test item per kg bw did not cause lethality in female rats during the 14 days observation period, resulting in a LD50 > 15 000 mg/kg bw.

Executive summary:

Female rats were subjected to test acute oral toxicity according to a protocol similar to OECD TG 401 (limit test). The test item was administered at one dose level of 15 000 mg/kg bw to10 female rats. During the 14 days observation period no animals died and there were no abnormalities found in necropsy, thus leading to an LD50 > 15 000 mg/kg bw.

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