Registration Dossier
Registration Dossier
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EC number: 277-552-6 | CAS number: 73612-29-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Erythema score not assessable due to red staining of the test substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
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:
- Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 277-552-6
- EC Name:
- Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 73612-29-0
- Molecular formula:
- C18H14N2O6S.Sr
- IUPAC Name:
- strontium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
- Test material form:
- solid: nanoform
- Details on test material:
- 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:
- - Physical state: powwder, red
- Analytical purity: the test substance has not been fully characterized analytically.
- Lot/batch No.: CS-485
- Stability under test conditions: has not been determined analytically.
- Storage condition of test material: room temperature
- Name of test material (as cited in study report): LITHOL RUBIN D 4569-SR-LACK
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Age at study initiation: young adult
- Mean weight at study initiation: Males: 2.7 kg, females: 2.4 kg
- Clipping of the fur: at least 15h
- Housing: individually
- Diet: Kliba-Labordiaet 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged test substance has been moistened with aqua bidest; because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 2 males, 1 female
- Details on study design:
- TEST SITE
- Area of exposure: upper third ofthe back or flanks, test patch 2.5 CM X 2.5 CM
- Type of wrap if used: test patches were secured in positino with a porous dressing (four layers of absorbent gauze + porous bandage).
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure with lutrol and lutrol/water (1:1)
READINGS: 30 - 60 minutes after removal of the test patches and 24h, 48 h, 72 h, 8d after the beginning of application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- other: no effects observable
- Remarks on result:
- other: not determineable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
Erythema score could not be read because of staining due to the colour of the test substance up to the 72 h reading. Day 8 reading no erythema were seen (score 0).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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