Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Remarks:
intraperitoneal injection
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable well documented study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
The study was conducted according to an internal BASF method. Test groups consisting of 5 animals/sex/group were treated with several doses of an aqueous suspension of the test substance applied intraperitoneally. After exposure, the animals were observed for a period of 14 d within which time signs of clinical toxicity as well as mortality were monitored and recorded. Animals found dead during the observation period were subjected to necropsy. At conclusion, the surviving animals were also sacrificed for the purpose of necropsy. The LD50 value was estimated on the basis of the observed mortalities.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Polychloro copper phthalocyanine
EC Number:
215-524-7
EC Name:
Polychloro copper phthalocyanine
Cas Number:
1328-53-6
Molecular formula:
C32HxClyCuN8
IUPAC Name:
polychloro copper phthalocyanine
Test material form:
solid
Specific details on test material used for the study:
- Analytical purity: ca. 98 %

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
Average body weight at study initiation:
- males: 30 g
- females: 26 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: suspension containing 0.5 % CMC and 1-2 drops Cremophor EL
Details on exposure:
Concentration of the test material in vehicle:
- 20 % (2000 mg/kg bw),
- 7 % (700 mg/kg bw)
-Amount of test material applied per gavage:
- 10 ml/kg bw for 2000 mg/kg bw
- 10 ml/kg bw for 700 mg/kg bw
Doses:
700, 2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: directly, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after injection, then on day 3, 4, 5, 6, 7, 10, 11, 12 and 13 until conclusion.
- Clinical symptoms and body weight were documented.
- Necropsy of survivors were performed. Deceased animals and those sacrificed at the end of the observation period (on day 14 after dosing) were necropsied.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality of 5 males and 5 females per dose was seen.
Clinical signs:
Some symptoms of poisoning (dyspnoea, apathy, spastic walk, stretching, unkempt fur, exsiccosis and poor general condition) were noted within the first 5 hours after application of the test substance. Green unkempt fur and green urine were seen in the 2000 mg/kg bw group on day 3 and 4.
Body weight:
The body weight gain was within the normal range, details can be seen in "Remarks on results including tables and figures".
Gross pathology:
Autopsy revealed incorporation of substance in the abdomen and coloration of fat tissue.

Any other information on results incl. tables

Table 1: Mean body weight of mice after intraperitoneal application of Heliogengrün D 8730

Dose level [mg/kg bw]

Males

Females

700

2000

700

2000

Day 3

30.8

33.2

29.2

24.8

Day 7

32.8

34.4

30.0

26.2

Day 13

34.4

33.0

30.4

28.0

Applicant's summary and conclusion