Registration Dossier
Registration Dossier
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EC number: 287-842-4 | CAS number: 85586-40-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 July to 02. September 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- FDA Federal Register 38, No 187, Patch-Test, occlusive scarified and intact skin
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt
- EC Number:
- 287-842-4
- EC Name:
- 5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt
- Cas Number:
- 85586-40-9
- Molecular formula:
- C29H19N3Na4O17S5 C29H23N3O17S5.xNa
- IUPAC Name:
- 5-(Benzoylamino)-4-hydroxy-3-((1-sulpho-6-((2-(sulphooxy)ethyl)sulphonyl)-2-naphthyl)azo)naphthalene-2,7-disulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Remazolbrillantrot F3B AKA-Muster
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- SPF Himalayan Albino Rabbits: Hoe:HIMK (SPFWiga)
Source: Hoechst AG
Food: ERKA 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing
Weight: 1.5 to 2 kg
In-life date: 13 to 16 July 1976
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded (3x3 cm) and shaved (3x3 cm) skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per shaved and abraded skin each
- Concentration (if solution): NA - Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure shaved and scarified skin: 2.5x2.5 cm
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: 6 to 8 cm wide PVC sheeting covered by elastic bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
SCORING SYSTEM: FDA Federal Register 38, No 187
Erythema and eschar formation (EEF) :
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation (EF):
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 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exp.) 4
Mean value of 6 animals
Primary Irritation Index (PII) = EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved / 4
EVALUATION:
0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Remarks:
- shaved skin
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- other: 24 h to 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- other: 24 h to 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- shaved skin
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- other: 24 h to 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- other: 24 h to 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- other: 24 h + 72 h
- Score:
- 0
- Max. score:
- 8
- Irritant / corrosive response data:
- no signs of irritation were noted
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- EU Classification: not irritating
- Executive summary:
The irritation potential of Reactive Red 180 was tested in the flank skin of 6 rabbits with shaved and abraded skin. No signs of skin irritation were noted either in shaved or in abraded skin with 500 mg undiluted test substance.
Consequently, the test substance is not irritating to skin.
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