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EC number: 305-644-9 | CAS number: 94891-43-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-02-05 to 1979-02-08
- 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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- - Principle of test: Patch test
- Short description of test conditions: Rabbits were dosed with 0.5 ml of the test substance. The dose was applied under a 2.5 cm square gauze pad to the shaved, intact skin site of each animal. Each treatment site was covered with PVC-foil (wide: 6 to 8 cm) and each treatment site was wrapped round with "Elastoplast" elastic adhesive dressing for a 24 hour period. At the end of the exposure period, the occlusive dressing and gauze pad were removed and the treatment site; observation direktly after removing of the patch and after 48, and 72h
- Parameters analysed / observed: skin irritation - GLP compliance:
- no
Test material
- Reference substance name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- EC Number:
- 305-644-9
- EC Name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- Cas Number:
- 94891-43-7
- Molecular formula:
- C32 H16 N8 Ni . C8 H11 N O6 S2 . 2 Na
- IUPAC Name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Albino-Himalayan-rabbit (Hoe: HIMK (SPFWiga))
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: inhouse
- Weight at study initiation: 1.5 - 2.5kg
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (ERKA 8300 (Futtermittelwerk Robert Koch oHG))
- Water (e.g. ad libitum): ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted test item - Duration of treatment / exposure:
- 24h exposure
- Observation period:
- 24, 48 and 72h after application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: patch area: 2,5cm²
- Type of wrap if used: bandage (Elastoplast (R))
REMOVAL OF TEST SUBSTANCE: no
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 24, 48, 72h after application
SCORING SYSTEM:
- Method of calculation: draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Other effects:
- - Other adverse local effects: dry and rough skin (5 animals)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was determined to be very slightly irritant according to the old scoring system and not irritating sccording to the recent scoring system. All symptoms were fully reversible within 72 h. The substance is not classifiable according to CLP criteria.
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