1-Dodecene, mixed with 1-decene and 1-octene, dimers, hydrogenated

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1991-10-28 to 1991-11-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

This study was conducted according to the EPA Good Laboratory Practice Standards outlined in 40 CFR Part 792, Federal Register Vol. 54, p. 158, 8/17/89 and according to EHSL SOP B.11.1.1. Method was used to assess dermal absorption

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated

EC Number:

500-183-1

EC Name:

Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated

Cas Number:

68037-01-4

IUPAC Name:

68037-01-4

Constituent 2

Reference substance name:

1-decene homopolymer, hydrogenated

IUPAC Name:

1-decene homopolymer, hydrogenated

Details on test material:

- Name of test material (as cited in study report): SHF-61
- Specific activity (if radiolabelling): 92.5 nCi/mg
- Storage condition of test material: in hood at room temperature

Radiolabelling:

yes

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 150-250g
- Housing: individual
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70
- Humidity (%): 50
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

The topical dose was administered to the clipped dorsal surface of the animals followed by covering the dosed area with a non-occlusive protective cell. After 24 h of exposure, the cell was removed and the dosed area wiped with olive oil.

Doses:

40mg (8mg/cm2 skin surface). Coverage is comparable to dermal administration at 2g/kg body weight

No. of animals per group:

5 female rats

Control animals:

no

Details on study design:

Five rats were administered a single topical dose of 40mg of SHF-61 containing 3.7uCi of 3H-SHF-61 (specific activity of 92.5 nCi/mg).

The topical dose was administered to the clipped dorsal surface of the animals followed by covering the dosed area with a non-occlusive protective cell. After 24 h of exposure, the cell was removed and the dosed area wiped with olive oil.

Animals were placed in individual metabolism cages. Urine and feces were collected at 24, 48, 72, and 96 hours post-dose. At the 96 hour time point, the animals were sacrificed by exposure to 100% CO2. The following tissues/organs were removed and analyzed for radioactivity: blood, small and large intestines, liver, kidney, stomach, retroperitoneal fat, treated (dose site) and untreated skin. The residual carcass was lyophilized prior to homogenization and measurement of 3H-activity. Radioactivity in the urine, urine wash and cage wash was counted. Fecal and most tissue samples were homogenized, oxidized and counted for radioactivity.

Results and discussion

Absorption in different matrices:

- Skin test site: 2.9%
- Skin, untreated site: 0.759%
- Blood: 0.14%
- Fat:0.158%
- Kidney: 0.02%
- Liver: 0.458%
- Small Intestine: 0.262%
- Large intestine 0.264%
- Stomach: 0.66%
- Carcass: 2.9%
- Urine: 2.0%
- Cage wash + cage wipe:
- Faeces: 7.8%
- Serial non-detects in excreta at termination:
- Receptor fluid, receptor chamber, donor chamber (in vitro test system):

Percutaneous absorption

Percutaneous absorption 1

Dose:

40mg

Parameter:

percentage

Absorption:

ca. 2.9 %

Remarks on result:

other: 24h

Remarks:

treated skin

Percutaneous absorption 2

Dose:

40mg

Parameter:

percentage

Absorption:

ca. 4.9 %

Remarks on result:

other: 24h

Remarks:

tissues

Percutaneous absorption 3

Dose:

40

Parameter:

percentage

Absorption:

9.8 %

Remarks on result:

other: 24

Remarks:

excreted (7.8% in the feces, 2.0% in urine)

Applicant's summary and conclusion

Executive summary:

Five female Sprague Dawley rats were administered a single topical dose of 40mg SHF-61 (8mg/cm² skin surface) fortified with ³H-labeled SHF-61 to determine the percutaneous absorption. The topical dose was administered to the clipped dorsal surface of the animals and covered with a non-occlusive protective cell.  After 24 h of exposure, the cell was removed and the dosed area wiped with olive oil.  Urine and feces were collected at 24, 48, 72, and 96 hours post-dose.  At the 96 hour time point, the animals were sacrificed and the amount of absorbed SHF-61 and its metabolites in the body was determined.  Nearly 18% (0.06 mg/cm²/hr) of the applied dose was absorbed in the rats with 2.9, 4.9% and 9.8% of the applied activity present in the treated skin, tissues and excreta, respectively.  The latter consists of 7.8% in the feces and 2.0% in the urine.  Low levels of activity were found in the liver (0.5%), untreated skin (0.8%) and remaining tissues (0.8%).

Detailed substance identity details supporting the use of 1-decene homopolymer, hydrogenated (CAS No. 68037-01-4) as read-across can be found in ‘Section 13-Assessment Reports’ of the IUCLID dossier.