2,9-bis(2-phenylethyl)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:

1979

Report date:

1979

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

EC Number:

266-564-7

EC Name:

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

Cas Number:

67075-37-0

Molecular formula:

C40H26N2O4

IUPAC Name:

7,18-bis(2-phenylethyl)-7,18-diazaheptacyclo[14.6.2.2²,⁵.0³,¹².0⁴,⁹.0¹³,²³.0²⁰,²⁴]hexacosa-1(23),2,4,9,11,13,15,20(24),21,25-decaene-6,8,17,19-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.

Specific details on test material used for the study:

- Purity: approx. 100%
- Physical state: solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner (breeder)
- Weight at study initiation: mean weight: males: 230 g, females: 180 g
- 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 % in water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 % in 0.5 % aqueous CMC
- Amount of vehicle (if gavage): 10 ml/kg

MAXIMUM DOSE VOLUME APPLIED: males: 2.3 ml; females 1.8 ml (10 ml/kg bw).

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
- Frequency of observations: daily (except on weekends)
- Frequency of weighing: before treatment and on days 2, 7 and 13
- Necropsy of survivors performed: yes

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 exposure period.

Clinical signs:

other: No abnormal observations, animals were in good general health throughout the study.

Body weight:

other body weight observations

Remarks:

Normal weight gain

Gross pathology:

No abnormal observations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the EU and GHS classification criteria, no classification is warranted as to acute oral toxicity for the test substance.

Executive summary:

The study was conducted according to an internal 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 (5000 mg/kg bw, 50 % in 0.5 % aqueous carboxymethyl cellulose). 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. No mortality, no abnormal clinical signs an no abnormal findings at necropsy were noted.