Registration Dossier
Registration Dossier
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EC number: 276-657-4 | CAS number: 72428-99-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)
- EC Number:
- 276-657-4
- EC Name:
- Hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)
- Cas Number:
- 72428-99-0
- Molecular formula:
- C32H13CuN8O4S2.(SO3H)m.(C4H11NO)n.(C8H18N) (3-m-n).C15H17N3
- IUPAC Name:
- hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG; 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 10 weeks
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet: pelleted standard Kliba 341, rabbit maintenance diet (ad libitum):
- Water: tap water (ad libitum):
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2
- Humidity (%): 55+-10
- Photoperiod. 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: propyleneglycol + saline, 70 : 30 parts
- Controls:
- no
- Amount / concentration applied:
- 0.5g of the moistened test material (propyleneglycol + saline, 70 : 30 parts)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males and 1 female
- Details on study design:
- TEST SITE
- Area of exposure: 3 cm x 3 cm
- Type of wrap if used: impermeable material and fastened to the body with adhesive tape.
SCORING SYSTEM:
according to Draize:
erythema formation: 0 - 4
edema formation: 0 - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #891, #892, #893 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- edema score
- Basis:
- animal: #891, #892, #893 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Other effects:
- No destructions or irreversible alterations of the treated skin were observed. No corrosion effect was evident of the skin.
In the area of application a slight dark-blue discoloration of the skin was observed in all rabbits within 1 to 72 hours after removal of the bandage.
The bodyweight gain of all rabbits was similar
No acute toxicological signs were observed in the animals during the test period, and no mortalities occurred..
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The substance was tested for skin irritation according to OECD guideline 404. 0.5 g of the substance moistened with propylenenglycol : salien = 70 : 30)was applied to3 albino white rabbits (2 male, 1 female) on an area of 3 cm x 3 cm on the clipped intact skin.
When the patch was in place it was covered with impermeable material and fastened to the body with adhesive tape.
After 4 hours the bandage and the substance were removed and the skin reation was observed after 1, 24, 48 and 72 hours.
In the area of application a slight dark-blue discoloration of the skin was observed in all rabbits within 1 to 72 hours after removal of the bandage.
No corrosion effect had occurred on the skin at each measuring interval.
Under the conditions of this experiment, the substance was found to cause no irritation when applied to intact rabbit skin.
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