Registration Dossier
Registration Dossier
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EC number: 696-145-8 | CAS number: 944730-39-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-10-29 to 2013-11-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine
- EC Number:
- 696-145-8
- Cas Number:
- 944730-39-6
- Molecular formula:
- C44H36CuN8O20S8 .4Na
- IUPAC Name:
- tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboraories UK Ltd, Leicestershire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.25-2.54 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): Free access to food (2930C Teklad Global Rabbit Diet) throughout the study
- Water (e.g. ad libitum): Free access to mains drinking water throughout the study
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12h continuous light (06:00 to 18:00) and 12h darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.5g of test material moistened with 0.5ml distilled water - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: moistened test material introduced to the back of each rabbit under a 2.5cm x 2.5cm cotton gauze patch.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4h
SCORING SYSTEM:
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of
exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 73687
- Time point:
- other: highest score at 1h, 24h, 48h & 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Blue coloured staining observed
- Irritation parameter:
- erythema score
- Basis:
- animal: 73688
- Time point:
- other: highest score at 1h, 24h, 48h & 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Blue coloured staining observed
- Irritation parameter:
- erythema score
- Basis:
- animal: 73689
- Time point:
- other: highest score at 1h, 24h, 48h & 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Blue coloured staining observed
- Irritation parameter:
- edema score
- Basis:
- animal: 73687
- Time point:
- other: highest score at 1h, 24h, 48h & 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 73688
- Time point:
- other: highest score at 1h, 24h, 48h & 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 73689
- Time point:
- other: highest score at 1h,24h, 48h & 72h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Primary Irritation Index 0/6= 0.0
Blue coloured staining, not preventing evaluation of skin responses, was noted at all treated skin sites throughout the study.
No evidence of skin irritation was noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. - Executive summary:
Introduction
This study was undertaken to assess the irritancy potential of the test item to the skin of the New Zealand white rabbit. The study was designed to be compatible with the following internationally accepted guidelines and recommendations:
OECD Guidelines for the Testing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion'
Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008
Results & Conclusions
The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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