Registration Dossier
Registration Dossier
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EC number: 500-130-2 | CAS number: 55818-57-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 27 to June 13, 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no certificate of analysis; animals exposed occasionally to humidity higher than 70%
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid
- EC Number:
- 500-130-2
- EC Name:
- 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid
- Cas Number:
- 55818-57-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of (4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane) and 2-propenoic acid
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 6 weeks (at least)
- Weight at study initiation: 1.0 kg (at least)
- Housing: Housed individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Pelleted diet (K-H from SSNIFF® Spezialdiaten GmbH, Soest, Germany), 100 g/day; hay (TecniLab-BMI BV, Someren, The Netherlands) provided at least three times a week
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 °C
- Humidity (%): 32-74%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours fluorescent light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Flank skin (150 cm2 )
- Type of wrap if used: Test material was applied to the skin using a metalline patch (2x3 cm) and then covered with Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed using tap water and/or watery ethanol (50% v/v)
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scoring system same as recommended by OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Mean individual scores at 24, 48 and 72 hours after exposure for the 3 animals were 0, 0, 0 for erythema score and 0, 0, 0 for oedema score
- Other effects:
- No
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not skin irritating
- Conclusions:
- Under the test conditions, Bisphenol A epoxy diacrylate is not classified as irritating to the skin.
- Executive summary:
In a primary dermal irritation study performed according to OECD guideline 404 and in compliance with GLP, three New-Zealand White male rabbits were dermally exposed to 0.5 mL of Bisphenol A epoxy diacrylate, under a semi-occlusive bandage for 4 hours to clipped skin of the flank (150 cm2). Animals were then observed for 7 days. Irritation was scored by the method of OECD Guideline 404 at 1, 24, 48 and 72 hours after exposure.
There was no irritant effect at any observation time point. In this study, Bisphenol A epoxy diacrylate is not a dermal irritant on male rabbits.
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