Salicylic acid

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented following scientific principles

Data source

Reference

Reference Type:

publication

Title:

In vivo percutaneous absorption of chemicals: a multiple dose study in rhesus monkeys

Author:

Bucks DAW, Hinz RS, Sarason R et al

Year:

1990

Bibliographic source:

Chem. Toxic. 28(2), 129-132

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The chemical was administered in a small volume to a lightly clipped area of the abdomen on a single- or multiple-dose exposure. Then, percutaneous absorption and urinary elimination were investigated.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Salicylic acid

EC Number:

200-712-3

EC Name:

Salicylic acid

Cas Number:

69-72-7

Molecular formula:

C7H6O3

IUPAC Name:

2-hydroxybenzoic acid

Details on test material:

Name of test material (as cited in study report): salicylic acid
- Radiochemical purity (if radiolabelling): greater than 95 %
- Specific activity (if radiolabelling): 27 mCi/mM
- Locations of the label (if radiolabelling): 14C-carboxyl

Radiolabelling:

yes

Test animals

Species:

monkey

Strain:

other: macaca mulatta (rhesus)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: California Primate Research Center (davis, CA)
- Age at study initiation: 7+/-3 yr
- Weight at study initiation: 5 +/- 2 kg
- Fasting period before study: data not available
- Housing: data not available
- Individual metabolism cages: no data
- Diet : ad libitum- Water : ad libitum
- Acclimation period: data not available

ENVIRONMENTAL CONDITIONS
data not available

Administration / exposure

Type of coverage:

not specified

Vehicle:

acetone

Duration of exposure:

14 days

Doses:

Females: 4 mg/cm²

No. of animals per group:

4

Details on study design:

TEST SITE
- Area of exposure: a lightly clipped area of the abdomen
- % coverage: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with soap and water (for single-dose experiments only)
- Time after start of exposure: 24hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mg/cm2

VEHICLE- Justification for use and choice of vehicle (if other than water): no data

USE OF RESTRAINERS FOR PREVENTING INGESTION:
yes (in the multiple-application experiments)

PHARMACOKINETIC STUDY (absorption, excretion)
- Tissues and body fluids sampled : urine
- Time and frequency of sampling: day 1: 0-4, 4-8, 8-12 and 12-24 hr; day 2-7: urine for each 24-hr period was combined

Results and discussion

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Any other information on results incl. tables

Penetration rate:
• Single application: 59 ± 32 %

• 14-day application (cumulative absorption):
1st day: 67 ± 17 %
8th day: 78 ± 18 %

Salicylic acid was absorbed across the skin. The amount penetrating from a single application could not be distinguished from that absorbed following a 14-day multiple application protocol.

Applicant's summary and conclusion

Conclusions:

No significant change in percutaneous absorption from that following the initial dose was observed following the eighth daily dose of a 14-day multidose regimen for each of the three penetrants considered. Cumulative percentage of 14C dose absorbed through the skin for SA: single dose: 59 ± 32 %; multiple dose: 1st one = 67 ± 17 %, 8th dose = 78 ± 18 %.

Executive summary:

In a percutaneous absorption (Bucks et al., 1990), salicylic acid was administered at a surface dose of 4 mg/cm² to a lightly clipped area of the abdomen either in a single-dose exposure or in a multiple-dose exposure. To quantify absorption, urine was collected for 7 days after dosing. Percutaneous absorption was observed. The amount penetrating from a single application (59 ± 32 %) could not be distinguished from that absorbed following either the first (67 ± 17 %) or the eighth (78 ± 18 %) daily dose of a 14-day multiple application protocol. Thus, under the conditions used, measurement of percutaneous absorption after a single application can be predictive of permeation when multiple skin contacts occur.