Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
03 June 1987 - 10 Dec 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report which meets basic scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 427 (Skin Absorption: In Vivo Method)
Version / remarks:
and OECD TG 417
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Hydroxyethyl acrylate
- Source: Sigma Chemical Company, St. Louis, MO (radiolabelled), Epoxy Products Department of The Dow Chemical Company, Freeport, TX (non-radiolabelled)
- Analytical purity: molar purity of 98.3 %, as determined by gas chromatography and infrared analysis (Hermann, 1991)
- Lot/batch No.: 059F9245 (radiolabelled), TB 881212 (non-radiolabelled)
- Radiochemical purity (if radiolabelling): 100 % as determined by high preformance liquid chromatography (HPLC, Analytical Data Sheet 89-397) (upon receipt). The radiochemical purity was evaluated repeatedly throughout the study (Analytical Data Sheets 90-9, 91-5, 90-124, 91-29, 91-33) and ranged from 100 % to 87 %.
- Specific activity (if radiolabelling): 6.3 mCi/mmol (MW 116)
- Locations of the label (if radiolabelling): uniformly labelled 14C-HEA
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories (Kingston, NY; Raleigh, NC)
- Age at study initiation: young adult animals
- Weight at study initiation: approx. 200 g
- Fasting period before study: feed withdrawal approximately 8 hr prior to administration of the 14C-HEA and food was returned about 4 hr post-dosing for all routes of exposure.
- Individual metabolism cages: no data
- Diet (ad libitum): certified rodent chow (Purina Mills Inc., Purina #5002)
- Water (ad libitum): municipal tap water
- Acclimation period: at least one week plus acclimation to glass Roth-type metabolism cages for at least 2 days prior to the administration


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
48 hr exposure
Doses:
12.5 mg/kg bw (corresponding to 15-20 µCi of radioactivity)
No. of animals per group:
4
Control animals:
no
Details on study design:
TEST SITE
- Area of exposure: interscapularly and as far anteriorly on the back as possible, 4 cm2
- Type of wrap if used: Immediately after dosing, the dosed area was covered with a piece of teflon@ film (4 an X 4 an) which was secured to the Stomahesive patch/well with surgical adhesive. The dosed area was then wrapped with veterinary bandaging tape.
- Time intervals for shavings or clipplings: before exposure

Results and discussion

Signs and symptoms of toxicity:
no effects
Dermal irritation:
no effects
Absorption in different matrices:
- Skin test site: 32.80 ± 6.16 %
- Carcass: 9.19 ± 0.93 %
- Urine: 27.38 ± 3.06 %
- Cage wash: 0.70 ± 0.28 %
- Faeces: 0.59 ± 0.41 %
- Expired air: 26.53 ± 2.73 % (CO2) + 0.36 ± 0.45 % (volatile organics)
Total recovery:
- Total recovery: 97.54 ± 1.06 %
Percutaneous absorption
Dose:
12.5 mg/kg bw
Parameter:
percentage
Absorption:
ca. 66 %
Remarks on result:
other: 48 hr

Applicant's summary and conclusion