1,4-dioxane

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

In vivo skin penetration studies of 2,4-toluenediamine, 2,4-diaminoanisole, 2-nitro-p-phenylenediamine, p-dioxane and N-nitrosodiethanolamine in cosmetics.

Author:

Marzulli F.N., Anjo. D.M., Maibach H.I.

Year:

1981

Bibliographic source:

Fd Cosmet. Toxicol. 19, 743-747.

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Monkeys were used in groups of between three and six. Site tested for skin penetration was the ventral forearm. Test substance (4 μg/sq . cm) was applied in methanol or a skin lotion. The skin-contact area ranged from 3 to 15 sq. cm2. In each experiment, a radiotagged (14C) chemical was applied to the uncovered skin of a restrained, clipped animal and was removed after 24 hr by washing with soap and water. Urine was collected over a 5-day period and was analysed for the radiolabel. A metabolism cage was used for collecting animal urine. Methods have been described in detail by Feldmann & Maibach (1969 & 1970).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dioxane

EC Number:

204-661-8

EC Name:

1,4-dioxane

Cas Number:

123-91-1

Molecular formula:

C4H8O2

IUPAC Name:

1,4-dioxane

Radiolabelling:

yes

Test animals

Species:

monkey

Strain:

other: Pitman-Moore Rhesus monkeys

Sex:

male/female

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Type of coverage:

open

Vehicle:

other: in methanol or a skin lotion

Duration of exposure:

24 hr

Doses:

dose: 4 mg/cm2; area: 3-15 cm2

No. of animals per group:

3-6

Results and discussion

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Absorption in different matrices:

One and five minutes after treatment with 1,4-dioxane in skin lotion 36% and 15% of the applied dose, respectively, were still detectable on the skin.

Total recovery:

Within 24 hours after treatment 2.3% and 3.4% of the applied radioactivity were excreted via the urine.

Percutaneous absorption

Key result

Time point:

24 h

Dose:

4 mg/cm2; area: 3-15 cm2

Parameter:

percentage

Absorption:

> 2.3 - < 3.4 %

Remarks on result:

other: Based on urine excretion only (e.g. does not include % in skin)