Octylamine

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Acceptable, well-documented publication/study report which meets basic scientific principles; but as read-across from supporting substance maximum reliability is 2. Read-across hypothesis: for details please see read-across report in IUCLID section 13.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1987

Materials and methods

Principles of method if other than guideline:

Examination of dermal absorption, metabolism and excretion

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dodecylamine

EC Number:

204-690-6

EC Name:

Dodecylamine

Cas Number:

124-22-1

Molecular formula:

C12H27N

IUPAC Name:

dodecan-1-amine

Details on test material:

- Name of test material (as cited in study report): lauryla 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

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Type of coverage:

other: patch test plaster

Vehicle:

other: squalane, castor oil, or triethyl citrate (TEC)

Duration of exposure:

24 hours

Doses:

concentrations: 50, 5, 05, and 0.05 %

No. of animals per group:

3

Control animals:

no

Details on study design:

APPLICATION OF DOSE:


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: raegent 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

Signs and symptoms of toxicity:

not specified

Dermal irritation:

yes

Any other information on results incl. tables

Read-across hypothesis: for details please see read-across report in IUCLID section 13.

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

At 5%, the absorption rate was in the order:

dodecyl amine>> dodecyl methylester >/= dodecyl alcohol >/= dodecyl acid > dodecane

Respiratory excretion: 80.1 +/- 8.1 % of the absorbed dose was metabolized and expired as CO2 within 24 hours.

Applicant's summary and conclusion

Conclusions:

Dodecylamine was dermally absorbed; there was an influence of the vehicle and concentration used. Dermal absorption of the amine was higher than that of other C12 compounds (alcohol, acid, ester).
Approx 80% of the absorbed dose was metabolised and expired as carbon dioxide within 24 hours.

Executive summary:

In a non-guideline study using hairless mice, the dermal absorption and excretion of dodecylamine 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 hours (Iwata, 1987).