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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
Copper,[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyanine-C,C,C-trimethanaminato(2-)-κN29,κN30,κN31,κN32]-
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:
other: 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.
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