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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
- Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7
Specific details on test material used for the study:
- Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Analytical purity: >85%
- Lot/batch No.: M200058
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff (R) K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +- 3 °C
- Humidity: 50 +- 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: sesame oil
Controls:
other: untreated shaved skin served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g test material, pasted with 0.4 ml sesame oil
Duration of treatment / exposure:
The exposure period was 4 hours.
Observation period:
72 hours after removal of the patches.
Number of animals:
3 females
Details on study design:
About 24 h before the start of the study the hair in the dorsal region of the body of the animals was removed with an electric clipper over an area of ca. 25 cm2. Only animals with intact skin were used.
Each animal was treated with the test material, the substance was evenly distributed over the whole surface of a 2.5 cm x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf AG). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 h, after the exposure all remnants of the test material were carefully removed from the skin with warm tap water.
Examinations of the skin took place 30 - 60 min as well as 24, 48 and 72 h after removal of the patches.
Erythema, eschar formation and edema were evaluated numerically, acc. to the score of Draize. All other changes of the skin were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

No signs of irritations were observed during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No signs of irritation were seen on the skin of the rabbits during the whole study period under the experimental conditions chosen here. Therefore, the test material has not to be classified according to GHS- or EU criteria.