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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication; study report which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): lauryl amine
- Molecular formula (if other than submission substance): C12H27N
- Molecular weight (if other than submission substance): 185.35
- Substance type: primary amine
- Analytical purity: >98%
- Specific activity (if radiolabelling): 14.9 µCi/mg
- Locations of the label (if radiolabelling): C1-position
Radiolabelling:
yes
Remarks:
14-C labeled compounds

Test animals

Species:
mouse
Strain:
other: HR/De
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: squalane, castor oil, or triethyl citrate (TEC)
Duration of exposure:
24 h
Doses:
concentrations: 50, 5, 05, and 0.05 %
No. of animals per group:
3
Control animals:
no
Details on study design:
APPLICATION OF DOSE:
patch test plaster

VEHICLE
- Justification for use and choice of vehicle (if other than water): exmination of vehicle influence on absorption
- Amount(s) applied (volume or weight with unit): 2 mL
- Concentration (if solution): 50 - 99.95%
- Purity: reagent grade


TEST SITE
- Preparation of test site: n.a; hairles mice were used
- Area of exposure: 200 mm² (patch test plaster, diameter 16 mm)
- Type of cover / wrap if used: plaster was covered with a thin rubber film to prevent peeling

SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: yes, plastic film

REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: no data
- Time after start of exposure: 24 hrs

SAMPLE COLLECTION
- Collection of urine and faeces: yes
- Collection of expired air: yes
- Analysis of organs: yes, skin

ANALYSIS
- Method type(s) for identification ( Liquid scintillation counting)

Results and discussion

Dermal irritation:
yes

Any other information on results incl. tables

Percutaneous absorption (approx. percent of dose)

Dodecylamine

vehicle

Concentration (%)

Squalane

Castor oil

TEC

50

6

4

5

5

28

22

13

0.5

57

5

10

0.05

30

6

4

The dermal absorption and excretion of dodecylamine in hairless mice was examined at various concentrations (50, 5, 0.5, and 0.05%) in different vehicles (squalane, used in cosmetics; castor oil, and triethylcitrate,TEC).

The dermal absorption reached 30 to 57% of the applied dose when dodecylamine was 0.05 to 5% in squalane. The dermal absorption of the amine was higher than that of other C12 compounds (lauryl alcohol, acid, or methyl ester). Approx 80% of the absorbed dose was metabolised and expired as carbon dioxide within 24 h.

Applicant's summary and conclusion