Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting 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:
no guideline followed
Principles of method if other than guideline:
internal test method
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
- Chemical name (as cited in study report): Perylen-3,4,9,10-tetracarbonsäure-bis-(4-phenylazo)-phenyl-imid
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:
mouse
Strain:
other: NMRI-Wiga
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight males: 26 g, females: 24 g
- Diet (e.g. ad libitum): HERILAN MRH-Haltung Alleinfutter für die Haltung von Mäusen, Ratten und Hamstern, Heinrich Eggersmann KG, Rinteln
- Weight at study initiation:
- Fasting period before study:
-

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % aequous solution
Details on exposure:
VEHICLE
- Concentration in vehicle: 20% supsension in 0.5% aqueous solution with carboxymethyl cellulose (w/v)
Doses:
2000 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, body weight

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
No mortalities occured.
Clinical signs:
Dyspnea, apathy, atony, spastic gait, ruffled fur. All symptoms reversed back to normal within 5 days.
Body weight:
ne effects reported
Gross pathology:
Intra-abdominal substance depositions

Applicant's summary and conclusion

Conclusions:
Under the conditions chosen, the test substance did not induce mortality in rats exposed intraperitoneally. Thus, the LD50 was concluded to be greater than 2000 mg/kg bw.