Registration Dossier
Registration Dossier
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EC number: 401-270-6 | CAS number: 122390-99-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Reactive Blue FC 15353
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchil Ltd. Huntingdon, UK and Interfauna Uk Ltd.
- Age at study initiation: adult
- Weight at study initiation:
- Housing: individual wire mesh, Type III-high
- Diet (e.g. ad libitum): ssniff K 4, ad libitum
- Water (e.g. ad libitum): water from automatic water dispenser, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (+/-2)°C
- Humidity (%):45 - 65%
- Air changes (per hr): 10-fold
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h Light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): in water
VEHICLE
- Amount(s) applied (volume or weight with unit): 500 mg in Water on Hansamed 'Hypoallergen' (Baiersdorf No. 2342) on a 6 cm² skin surface - Duration of treatment / exposure:
- 4 h
- Observation period:
- 24, 48 and 72 h after removal of the patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal region of the body
- % coverage: 6 cm²
- Type of wrap if used: test substance evenly distributed on sterile plaster. The plaster was fixed to the prepared skin area and then coverd with semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 h
SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- other: 1, 24, 48 and 72 hours and 7 and 14 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- other: 1, 24, 48 and 72 hours and 7 and 14 days
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No abnormalities detected in any of the tested animals at different time points up to 72 h
- Other effects:
- None
Any other information on results incl. tables
No signs of irritations were observed during the whole observation period
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritating to rabbit skin
- Executive summary:
A study was conducted to assess the skin irritation potential of test substance to the rabbit skin according to EU Method B.4. and OECD Guideline 404 in compliance with GLP.
Three animals were treated with 500 mg of the test substance pasted with water using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal.
No signs of irritation were observed during the whole observation period.
Under the test conditions, the test substance was considered to be non-irritating to rabbit skin.
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