Diaminotoluene

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment (additionally labeling of the tables unclear)

Cross-reference

Reason / purpose for cross-reference:

reference to other study

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 FN, Anjo DM & Maibach HI

Year:

1981

Bibliographic source:

Food Cosmet.Toxicol. 19: 743-7

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Remarks:

; GLP was no compulsory at the time the study was conducted

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-m-phenylenediamine

EC Number:

202-453-1

EC Name:

4-methyl-m-phenylenediamine

Cas Number:

95-80-7

Molecular formula:

C7H10N2

IUPAC Name:

4-methylbenzene-1,3-diamine

Details on test material:

- Name of test material (as cited in study report): 2,4-TDA dihydrochloride
- Specific activity (if radiolabelling): 2.78 mCi/mmol
- Locations of the label (if radiolabelling): uniformly ring labeled
- Supplier: New England Nuclear

Radiolabelling:

yes

Remarks:

14C

Test animals

Species:

monkey

Strain:

other: Rhesus

Sex:

male/female

Details on test animals or test system and environmental conditions:

no further data

Administration / exposure

Type of coverage:

open

Vehicle:

acetone

Duration of exposure:

24 h

Doses:

4 µg/cm2 (area exposed 3-15 cm2, therefore it can be concluded that 12 - 60 µg TS were applied)

No. of animals per group:

3 - 6

Control animals:

no

Details on study design:

TEST SITE
- Preparation of test site: clipping (no data on the time period between clipping and exposure available)
- Area of exposure: abdomen

USE OF RESTRAINERS FOR PREVENTING INGESTION: yes

REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: washing with soap and water
- Time after start of exposure: 24 h

SAMPLE COLLECTION
- Collection of urine: over a 5 day period with the intervals: 0-4 h, 4-8 h, 8-12 h, 12-24 h, 24-48 h, 48-72 h, 72-96 h (no information whether the urine between 96-120 h was really sampled or analysed is available)
- no information on whether the urine was pooled is available

ANALYSIS
- Method type for identification: Liquid scintillation counting for determination of overall radioactivity in urine

Results and discussion

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Percutaneous absorption

Remarks on result:

other:

Any other information on results incl. tables

- The absorption rate of [14C]2,4 -TDA in monkey skin was 53.8 ± 15.4% of the dose during 24 h, as extrapolated by the amount of radiotracer (14C) found in the urine over a 5-day period.

- 43% of the dose absorbed is excreted in urine within 96 h. The peak urinary excretion was between 8-12 h after application of the dose.

Table 1: Percentage of the [14C]2,4-TDA dose excreted by urine during the indicated interval

	Monkey [% of the absorbed dose]
0-4 h	1.0
4-8 h	7.6
8-12 h	12.7
12- 24 h	9.3
24 - 48 h	7.4
48 -72 h	3.7
72 -96 h	1.8
Total	43.5

- excretion table was wrongly labeled.