Registration Dossier

Diss Factsheets

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:
other: Meets generally accepted scientific standards (without detailed documentation)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976
Reference Type:
other company data
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
5 mice per sex per dose were administered a single dose of the test substance via intraperitoneal injection. Clinical signs and body weight were monitored and necropsy was carried out at termination or after death if an animal died during the study. Observation period was until day 7 following treatment.
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Reference substance name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
EC Number:
249-125-4
EC Name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
Cas Number:
28654-73-1
Molecular formula:
C47 H49 Cu N11
IUPAC Name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
Details on test material:
- Physical state: solid
- Analytical purity: ca. 93%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: NMRI-Ivanovas mice
- Weight at study initiation (mean): 27.2 g (males); 19.6 g (females)


Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous suspension in 0.5% CMC-solution
Details on exposure:
test substance was applied as a 35% suspension in 0.5% CMC solution (ca. 28.5 mL/kg bw)
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5 mice
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations after application: day 0 (3 and 20 min and 3 hours), day 1, 2, 5 and 6
- Frequency of weighing: before application and after 2 and 7 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
3 min after application: dyspnoea, tremor and hunched body posture
20 min after application: dyspnoea
3 h and on day 1 after application: hunched body posture, slight apathy
2 days after application: males: no clinical signs were observed; females: dyspnoea, loss in body weight
5 and 6 days after application: no clinical signs were observed
Body weight:
There was no test item-related effect on the body weight
Mean weights: males: 27 g (day 0), 28 g (day 2) and 30 g (day 7); females: 20 g (day 0), 19 g (day 2) and 21 g (day 7)
Gross pathology:
Intraabdominal substance residues, sporadic adhesions

Applicant's summary and conclusion