Registration Dossier
Registration Dossier
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EC number: 235-285-2 | CAS number: 12158-74-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The test was conducted between 25 November 2010 and 28 November 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dicopper hydroxide phosphate
- EC Number:
- 235-285-2
- EC Name:
- Dicopper hydroxide phosphate
- Cas Number:
- 12158-74-6
- Molecular formula:
- Cu2HO5P
- IUPAC Name:
- dicopper hydroxide phosphate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): dicopper hydroxide phosphate
-CAS Number: 12158-74-6
- EC Number: 235-285-2
- Purity test date: 15/01/2009
- Lot/batch No.: 08004
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data (young adults)
- Weight at study initiation: <2 kg
The animals were acclimated and permanently controlled by veterinarians according to DIN EN ISO 10993-2. They were immunised against myxomatosis and RHD.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of test material moistened with a small amount of water. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (as no effects were noted it was not necessary to observe the animals for any longer).
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: The fur on the back of three rabbits was closely clipped on both sides of the spinal column (10 x 10 cm).
- Type of wrap if used: 4-ply gauze patches (25 x 25 mm). The gauze patches were covered with a non-occlusive gauze patch and wrapped with an occlusive bandage for 4 hours.
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the contact time (4 hours) the dressings were removed and residual substance was washed off with warm water. The skin was blown dry.
SCORING SYSTEM:
see table 1 below.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- No loss of bodyweight or other adverse systemic effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material (dicopper hydroxide phosphate) did not cause skin irritation.
- Executive summary:
The test material (dicopper hydroxide phosphate) did not cause skin irritation and as such is not considered to be classified in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
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