Registration Dossier
Registration Dossier
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EC number: 608-403-9 | CAS number: 297132-04-8
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:
- other: GLP-compliant guideline study, available as unpublished report, Test itm purity less than 80%., fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24 2000
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany
Test material
- Reference substance name:
- 4-({[4-(acryloyloxy)butoxy]carbonyl}oxy)benzoic acid
- EC Number:
- 608-403-9
- Cas Number:
- 297132-04-8
- Molecular formula:
- C15H16O7
- IUPAC Name:
- 4-({[4-(acryloyloxy)butoxy]carbonyl}oxy)benzoic acid
- Details on test material:
- - Name of test material (as cited in study report): 4-(4-Acryloyloxy-butoxycarbonyloxy)-benzoic acid
- Degree of purity / content: 66.7 area %
- Physical state / appearance: Solid / white
- Homogeneity: The test substance was homogeneous by visual inspection.
- pH-value: of a 10% aqueous preparation: about 4
- Storage conditions: Room temperature, protected from humidity and light.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 6 - 7 months
- Weight at study initiation: 3.76 - 3.91 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung ("GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- minimally moistened
- Controls:
- other: untreated skin of the animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g (ca 0.3g adjusted for purity) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 (2 males and 1 female)
- Details on study design:
- TEST SITE
- Clipping of the fur: At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animal(s).
- Area of exposure: 2.5 cm X 2.5 cm
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 h
SCORING SYSTEM: evaluation of skin reactions is performed according to the quoted guidelines.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24-48-72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Moderate erythema (grade 2) was observed in all animals immediately after removal of the patch. Slight erythema (grade 1) persisted in 2 animals up to 1 hour and in 1 animal up to 24 hours after removal of the patch.
- No other cutaneous reactions were observed during the study.
- The cutaneous reactions were reversible in 2 animals within 24 hours and in 1 animal within 48 hours after removal of the patch.
- Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0 for edema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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