Registration Dossier
Registration Dossier
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EC number: 701-372-3 | CAS number: -
Skin irritation / corrosion
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:
- 2 001
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- A characterization of the test material regarding presence of particles in the nanometer was not performed at that time. It is considered to be representative of the current material.
- 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
Constituent 1
- 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.
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