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Toxicological information

Skin irritation / corrosion

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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:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.