4,10-dibromodibenzo[def,mno]chrysene-6,12-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:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

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:

4,10-dibromodibenzo[def,mno]chrysene-6,12-dione

EC Number:

224-481-3

EC Name:

4,10-dibromodibenzo[def,mno]chrysene-6,12-dione

Cas Number:

4378-61-4

Molecular formula:

C22H8Br2O2

IUPAC Name:

4,10-dibromonaphtho[7,8,1,2,3-nopqr]tetraphene-6,12-dione

Test material form:

solid: nanoform

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: W. Gassner, Sulzfeld
- Weight at study initiation: male 130 to 160 g, female 105 to 110 g
- Fasting period before study: 16 hours
- Housing: conventional housing, 5 animals per cage
- Diet: Ssniff P 10 pellets, ad libitum
- Water. tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 % suspension

Doses:

0 and 5000 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

yes

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:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no animals died within the 14 days observation period

Mortality:

- no deaths occurred

Clinical signs:

other: - post application faeces was stained red - ruffled coat

Gross pathology:

No macroscopic findings at scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Regulation (EC) 1272/2008

Conclusions:

Single application of 5000 mg test item per kg bw did not cause lethality in male and female rats during the 14 days observation period, resulting in a LD50 > 5000 mg/kg bw.

Executive summary:

Male and 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 5000 mg/kg bw to 5 male and 5 female rats. During the 14 days observation period no animals died and there were no ab normalities found in necropsy, thus leading to an LD50 > 5000 mg/kg bw.

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