2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

EC Number:

221-264-5

EC Name:

2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

Cas Number:

3049-71-6

Molecular formula:

C48H26N6O4

IUPAC Name:

2,9-bis[4-(phenyldiazenyl)phenyl]isoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone

Details on test material:

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: average weight males: 180 g, females: 160g
- Diet (e.g. ad libitum): HERILAN MRH-Haltung Alleinfutter für die Haltung von Mäusen, Ratten und Hamstern, Heinrich Eggersmann KG, Rinteln

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % aequous solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% supsension in 0.5% aqueous solution with carboxymethyl cellulose (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

None of the animals died during the observation period.

Clinical signs:

other: No abnormal findings. Red stained feces were reported. All animals recovered.

Gross pathology:

No deviations from normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was >5000 mg/kg bw.

Executive summary:

In an acute oral toxicity study comparable to OECD guideline 401, Sprague-Dawley rats (5/sex/dose) were administered the test substance at a single dose of 5000 mg/kg bw by gavage followed by a 7-day observation period. None of the animals died during the exposure period. Animals did not display any clinical signs, except red stained feces. No abnormal findings were made at necropsy.