C.I. Pigment Violet 55

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,9-dimethoxy-5,12-dihydroquino[2,3-b]acridine-7,14-dione and 2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

EC Number:

941-220-5

Cas Number:

1126076-86-5

Molecular formula:

PV54: C22H16N2O4 PR202: C20H10Cl2N2O2

IUPAC Name:

Reaction mass of 2,9-dimethoxy-5,12-dihydroquino[2,3-b]acridine-7,14-dione and 2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Doses:

2000 mg/Kg

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

7.1. Mortality No mortality occurred.

7.2. Clinical signs Hunched posture was noted for all animals between Days 1 and 4. Dark or purple discolouration of the faeces was noted for all animals between Days 1 and 3. Purple discouloration of the back was noted for one animal on Days 2 and 3. These findings were considered to be due to staining by the test substance.

7.3. Body weights The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.

7.4. Macroscopic findings No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The oral LD50 value of C. I. Pigment Violet 55 in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, C. I. Pigment Violet 55 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments). Final