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Registration Dossier
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EC number: 419-480-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 January 1995 to 24 January 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to recent EU and OECD test guidance. GLP is assumed, given the references and QA procedures, although is not specifically mentioned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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 OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP is assumed, given the references and QA procedures, although is not specifically mentioned.
Test material
- Reference substance name:
- -
- EC Number:
- 419-480-1
- EC Name:
- -
- IUPAC Name:
- Reaction mass of tetrasodium 2-((1-(3-(6-fluoro-(4-((N-(2-(2-sulfatoethanesulfonyl)ethyl)-N-phenyl)amino)-1,3,5-triazin-2-ylamino)-2-hydroxy-5-sulfonatophenylazo)-1-phenylmethyl)azo)-4-sulfonatobenzoate cuprate (4-) and trisodium 2-((1-(3-((4-(N-(2-ethenesulfonylethyl)-N-phenyl)amino)-6-fluoro-1,3,5-triazin-2-ylamino)-2-hydroxy-5-sulfonatophenylazo)-1-phenylmethyl)azo)-4-sulfonatobenzoate cuprate (4-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Blue FC 75311
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Age at study initiation: Adult
- Weight at study initiation: Average 3.9 kg
- Housing: Individually housed in stainless steel cages
- Diet (e.g. ad libitum): Standard diet, approx 100 - 200g per animal/day; once per day in the monring
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50 - 70
- Air changes (per hr): 12 - 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illumination from 6 am to 6 pm
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg moistened with deionised water. - Duration of treatment / exposure:
- Exposure 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: hypoallergenic Hansamed patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With water
- Time after start of exposure: 4 hours
SCORING SYSTEM: DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: due to staining of the skin was erythema evaluation not possible between day 1 and day 7
- Irritant / corrosive response data:
- Evaluation of skin erythema was not possible in all three animals due to the intense colouration by the test substance. Nevertheless, no other inflammatory signs (eschar or oedema formation) became apparent within the observation period of 7 days. Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as 'not irritating to the skin’.
- Other effects:
- Areas of exposed skin were stained the colour of the test sample.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Substance not irritant.
- Executive summary:
Study conducted to recent EU test guidance 92/69/EEC B4 and OECD Guideline 404.
Test substance was found not to be irritant.
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