C.I. Pigment Red 282

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 5 APR 1979 to 19 APR 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: no individual data included in report

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

EC Number:

213-879-2

EC Name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

Cas Number:

1047-16-1

Molecular formula:

C20H12N2O2

IUPAC Name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in-house breeding (Hoe WISKf (SPF71))
- Weight at study initiation: 160 to 176 g
- Fasting period before study: 16 hours
- Housing: in plastic cages in groups
- Diet: Altromin 1324 (Altromin GmbH, Lage/lippe, Germany), ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: starch mucilage (2%)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 12.5% suspension in 2% starch mucilage

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

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

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Remarks on result:

other: no animals died within the 14 days observation period

Mortality:

- no deaths occured

Clinical signs:

other: - dye was excreted in the faeces - no other clinical signs observed

Gross pathology:

- in the animals sacrificed at the end of the observation period no macroscopically visible changes were found

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP Regulation

Conclusions:

Single application of the limit dose of 10000 mg test item per kg bw did not cause lethality in female rats during the 14 days observation period, resulting in a LD50 > 10000 mg/kg bw.

Executive summary:

Female Wistar rats were subjected to test acute oral toxicity. The test item was administered at the limit dose of 10000 mg/kg bw to ten rats. During the 14 days observation period no animals died and there were no changes found in necropsy, thus leading to a median lethal dose (LD50) > 10000 mg/kg bw.

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