Registration Dossier

Diss Factsheets

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:
other: Comparable to guideline study with acceptable restrictions (incomplete documentation)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(application volume exceeded 20 mL/kg bw in the highest dose group, 2 dose groups, 7 day observation period)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

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:
Please refer to confidential details on test material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Weight range at study initiation: 185 -250 g (males); 164 - 196 g (females)

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous suspension in 0.5% CMC
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 35% (10000 mg/kg bw), 15% (1000 mg/kg bw)

MAXIMUM DOSE VOLUME APPLIED: 28.6 mL/kg bw

Doses:
1000 mg/kg bw (6.7 mL/kg bw) and 10000 mg/kg bw (28.6 mL/kg bw)
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations after application: day 0 (after 2-3 hours) and once daily on working days
- Frequency of weighing: before application, on day 2 - 3 and at termination
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1/10 animal died on day 2 of observation
Mortality:
10000 mg/kg bw: 1 animal (female) died on day 2 of observation
1000 mg/kg bw: no mortality
Clinical signs:
10000 mg/kg bw: On day 1, blue colouring of faeces and slight apathy were observed. Within 2 days, the symptoms were fully reversed.
1000 mg/kg bw: On day 1, blue colouring of faeces was observed. On day 2, faeces colour was normal.
Body weight:
There was no test item-related effect on body weights.
10000 mg/kg bw: males: 197 g (day 0), 218 g (day 2) and 216 g (day 8); females: 171 g (day 0), 179 g (day 2) and 171 g (day 8)
1000 mg/kg bw: males: 228 g (day 0), 267 g (day 3) and 256 g (day 8); females: 187 g (day 0), 200 g (day 3) and 189 g (day 8)
Gross pathology:
10000 mg/kg bw: animal that died: substance residue was found in the thorax. No abnormalities were found in the other animals.
1000 mg/kg bw: no abnormalities were found.

Applicant's summary and conclusion