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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Acute toxicity upon intraperitoneal injection
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
29H,31H-phthalocyanine
EC Number:
209-378-3
EC Name:
29H,31H-phthalocyanine
Cas Number:
574-93-6
Molecular formula:
C32H18N8
IUPAC Name:
29H,31H-phthalocyanine
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Heliogenblau MFA
- Analytical purity: ca. 100 %

Specific details on test material used for the study:
- Name of test material (as cited in study report): Heliogenblau MFA
- Analytical purity: ca. 100 %

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: 26 g
- females: 24 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),

-Amount of test material applied per gavage:
- 10 ml/kg bw for 2000 mg/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex
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 1, 4, 5, 6, 7, 8, 11, 12, 13 and 14 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
Based on:
test mat.
Remarks on result:
other: No mortality was observed.
Mortality:
No mortality of 5 males and 5 females per dose was seen.
Clinical signs:
Some symptoms of poisoning (dyspnoea, apathy, staggering, unkempt fur, exsiccosis and a poor general condition) were noted within the first 5 hours after application of the test substance.
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.

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

2000

 

2000

 

Day 3

29.2

26.4

Day 7

30.8

27.8


Day 13 34.433.0   Day 13

34.2

28.6 

Applicant's summary and conclusion