Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 December 2007-21 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): S-500
- Physical state: yellow powder
- Lot/batch No.: MF1456-2345
- Expiration date of the lot/batch: 18 August 2011
- Storage condition of test material: At room temperature in the dark
- Stability under storage conditions: Stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: Individually in labeled cages with perforated floors
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day, hay at least three times a week.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7 – 21.7
- Humidity (%): 26 - 59
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: watery ethanol (50% v/v)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.6 ml
- Concentration (if solution): 50% v/v - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 150 square centimeters (10x15 cm)
- % coverage: test site covered by 100%
- Type of wrap if used: metalline patch mounted on Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using tap water and watery ethanol (50% v/v)
- Time after start of exposure: 4h
SCORING SYSTEM: according to OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No skin irritation was caused by 4 hours exposure to S-500.
There was no evidence of a corrosive effect on the skin.
Yellow staining of the treated skin by the test substance was observed throughout the observation period, but did not hamper the scoring of the skin reactions.
No remnants of the test substance were present on the skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results, S-500 does not have to be classified and has no obligatory labeling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004) and EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).
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