Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
Deviations:
no
Principles of method if other than guideline:
6 male albino New Zealand white rabbits were used for each trial. After clipping, the skin of the left flank of the animals was left intact, the right flank was scarified. The animals were treated for 24 h using occlusive conditions. The application site, treated with the liquid test substance, was covered with a gauze pad and wrapped with adhesive tape. After the application time, the patches/tape were removed. The primary irritation index was evaluated after 25 and 72 hours after start of application of the test material. The animals were observed for one week, at day 7 another reading was made.
GLP compliance:
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:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: at the start of the test, the animals weighed between 2.5 and 3.5 kg
- Housing: Rabbits were kept in individual cages (540 x 360 x 315 mm) or in restraining devices
- Diet: 200 g of food per animal per day (Granules Lapin "entretien", Sanders)
- Water: softened and filtrated water ad libitum, automatically given

ENVIRONMENTAL CONDITIONS
- Temperature (°C): minimum 20 °C
- Air changes: ventilation (renewal of air 12 times per hour )
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: The rabbits were clipped; the skin of the left flank was left intact ; the skin of the right flank was scarified.
Vehicle:
other: olive oil
Controls:
no
Amount / concentration applied:
0.5 g pure test material, applied in paste form (mixed with olive oil)
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE
- The right flank was scarified with a sterile scalpel blade, making three parallel superficial incisions 2 cm long and 0.5 cm apart. The incisions were epidermal.
- The test substance was applied to the rabbit skin, using the right, previously scarified flank and the left intact one, at a rate of 0.5 g test substance per area and animal.
- Occlusion: A loaded gauze patch was applied to intact and scarified skin. The test substance and the gauze pads were kept in contact with the skin by a patch. Patches were then fastened to the body with adhesive tape.
- Vehicle: olive oil (0.5 g in 0.65 ml of neutralized sterilized olive oil per zone)
- Removal of the test substance: after 24 hrs
- Post exposure period: 7 days

EXAMINATION
- Observation period: after exposure at 25 h, at 72 h and 7 days
- Scoring system: readings were made of both scarified and no scarified zones, following the scale proposed by Draize. Only cutaneous reactions observed after treatment of intact skin are considered relevant for hazard assessment and are described in detail.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: 24-72 h
Score:
1.12
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Slight desquamation was seen in 2 animals after 7 days; first reading time point was in fact 25 hours instead of 24 hours.
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 5 animals
Time point:
other: 24-72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: first reading time point was in fact 25 hours instead of 24 hours.
Irritant / corrosive response data:
Treatment with the test substance resulted in only one out of 6 rabbits in very slight edema after 24 h. The evaluation of erythema after 24 hours was impossible in 2 rabbits due to treatment related colouring of the skin. Very slight to well defined erythema were noticed in 4 rabbits where irritation was reversible after 7 days. Slight desquamation was seen on intact skin in 2/6 animals after 7 days.

Any other information on results incl. tables

Table 1: OECD Draize scores for edema after 24 hours exposure to the test substance:

Rabbit No.

 

1

2

3

4

5

6

Erythema

 

 

 

 

25 h

0

*

1

*

2

0

72 h

1

*

2

*

2

1

7 d

S

§

0

0

0

S

Edema

 

 

 

 

25 h

0

0

0

0

1

1

72 h

0

0

0

0

0

0

7 d

0

§

0

0

0

0

S = slight desquamation;  

C = Formation of a scab without underlying necrosis

* = Reading of erythema was impossible on two rabbits, because of green colouration through the test material

§ = Rabbit No. 2 died on day 6 and was not replaced

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met