Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
EC Number:
205-685-1
EC Name:
29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
Cas Number:
147-14-8
Molecular formula:
C32H16CuN8
IUPAC Name:
[29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Analytical purity: 100 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding Farm VELAZ
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 236-278 g
- Housing: individually in plastic breeding cage Velaz T4
- Diet: DOS 2b - standard pelleted diet, ad libitum
- Water: drinking tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
The amount of the test substance for each animal was weighed (acc. to its body weight) and moistened with water for injection immediately before application.
Approx. 24 h before application of the test substance, the fur on the back of the animals was shaved at area about 6 cm x 6 cm.
Aliquot part of the test material was applied on the depilated area of skin. The application site was covered by mull, plastic foil and held in contact by plaster (strapping). After 24 h the occlusive dressing and the remains of the test substance were removed.
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
Body weight:
Animals were weighed before application, at 8th day and before euthanasia of animals. Average body weight in a group was calculated from individual body weights.

Clinical examination:
After application of the test material the animals were observed individually. Observations included changes of health conditions. Observations were performed daily during the 14 days observation period.

Pathological examination:
All test animal survivors to the end of the study were sacrificed on the 15th day and gross necropsy was carried out. Normally the nutritious state, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived the 14 day observation period and the day of sacrifice.
Clinical signs:
No clinical signs of toxicity were observed during the study period.
Body weight:
Body weight gains were within the the physiological range.
Gross pathology:
No individual records of macroscopic changes were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met