Registration Dossier
Registration Dossier
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EC number: 226-109-5 | CAS number: 5281-04-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Clinical signs and body weights not reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Body weights and clinical signs were not reported.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 226-109-5
- EC Name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5281-04-9
- Molecular formula:
- C18H14N2O6S.Ca
- IUPAC Name:
- calcium 3-hydroxy-4-[(1E)-2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-2-carboxylate
- Test material form:
- solid: nanoform
- Details on test material:
- - Name of test material (as cited in study report): Irgalite Rubine 6BL G861831
- Substance type: pigment
- Physical state: solid
- Purity test date: not indicated
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured in August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- described as red powder
- Analytical purity: 89% Pigment Red 57:1
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Irgalite Rubine 6BL G861831
- Substance type: pigment
- Physical state: solid
- Purity test date: not indicated
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured in August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- described as red powder
- Analytical purity: 89% Pigment Red 57:1]
Test animals
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: (Hylyne Commercial Rabbits Ltd
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.71 kg (males) and 2.5 kg (females)
- Housing: single caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10h light daily
IN-LIFE DATES: From: July 21, 1987 To: July 24, 1987
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 50% aqueous solutionof polyethylene glycol
- Controls:
- not required
- Amount / concentration applied:
- 500 mg per animal
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72 hours. As no findings were observed, the experiment was discontinued.
- Number of animals:
- 2 males and 2 females
- Details on study design:
- Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. One test site close to the mid-line of the back was used on each rabbit.
2.5 g of the test compound was mixed with 4 ml of a 50% aqueous solutionof polyethylene glycol to give a suspension of 5 ml, 1.0 ml of which was applied to the test site on a 6 cm square gauze pad. This was covered with aluminium foil secured with "Transpore" surgical tape. The test site was then covered by a 6" wide 'Coban' self adhesive bandage in order to retain the test substance in close contact with the skin. After 4 hours the dressing was removed and the compound residue rinsed from the application site using lukewainn water. Sites were assessed for oedema and erythema 30 - 60 minutes after removal of the occlusive dressing. Further assessments were made at 24, 48 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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