Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study predated GLP but followed accepted scientific standards at the time of performance.

Data source

Reference

Reference Type:

publication

Title:

Metabolism of cutaneously applied surfactants

Author:

Drotman RB

Year:

1977

Bibliographic source:

Cutan. toxic., 3, 95-109

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The labeled material was applied to the skin of experimental animals. Urine, feces and carbon dioxide were collected at intervals for a predetermined period of time and finally the excess of substance was washed from the application site and the experimental animals were sacrificed. The excreta, skin washings, various organs and especially the skin at the application site were then assayed for radioactivity. When it was appropriate, biotransformation products were isolated and identified.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyldioctadecylammonium chloride

EC Number:

203-508-2

EC Name:

Dimethyldioctadecylammonium chloride

Cas Number:

107-64-2

Molecular formula:

C38H80N.Cl

IUPAC Name:

N,N-dimethyl-N-octadecyloctadecan-1-aminium chloride

Constituent 2

Reference substance name:

1-Octadecanaminium,N,N-dimethyl-N-octadecyl chloride

IUPAC Name:

1-Octadecanaminium,N,N-dimethyl-N-octadecyl chloride

Constituent 3

Reference substance name:

Dioctadecyldimethylammonium chloride

IUPAC Name:

Dioctadecyldimethylammonium chloride

Details on test material:

- Name of test material (as cited in study report):Dioctadecyl dimethyl[1- 14C] ammonium chloride
- Specific activity (if radiolabelling): 30 µCi
- Locations of the label (if radiolabelling): First carbon of one alkyl group

No other data available

Radiolabelling:

yes

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data available

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Duration of exposure:

72 h (collection period)

Doses:

- Nominal doses: 10 mg (corresponding to 30 µCi) over a 5 - 8 cm area on the back of the rabbits

No. of animals per group:

one group of 4 rabbits

Control animals:

no

Details on study design:

TEST SITE
- Area of exposure: back of the animal
- % coverage: 5- 8 cm2
- The rabbits were restrained for 72 hours so they could not lick the material from thair backs or rub against their cages.

Results and discussion

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Absorption in different matrices:

Administered radioactivity detected over a 72 hour-period expressed as mean +/- SEM (n=4)

- Skin test site: 88 ± 2.3%
- Skin, untreated site: 0.2% ± 0.1
- Urine: 0.15% ± 0.0
- Faeces: 0.16% ± 0.0
- Expired air: 0.27% ± 0.0
- Cage wash + cage wipe: 0.29% ± 0.0

Total recovery:

- Total recovery: 89 ± 2.4 expressed as mean +/- SEM (n=4)

Percutaneous absorption

Dose:

10 mg

Parameter:

percentage

Absorption:

< 1 %

Remarks on result:

other: 72 hours

Remarks:

Only traces of administered radioactivity detected over a 72 h period. Dermal absorption of DODMAC considered to be very low.

Applicant's summary and conclusion

Conclusions:

The dermal absorption of the Dioctadecyldimethylammonium chloride was very low.

Executive summary:

After dermal administration of 10 mg (≈ 30μCi) 14C-labelled test substance to the back of each of four rabbits over a 5 x 8 cm area most of the radioactivity remained at the site of application (88 ± 2.3%). Only traces of administered radioactivity were detected over a 72 h-period in urine (0.15 %), faeces (0.16 %), exhaled carbon dioxide (0.27 %), other skin (0.2%) and cage wash (0.3%).

Based hereupon, the dermal absorption and the concentration of Dioctadecyldimethylammonium chloride in the skin can be assumed to be very low.