Registration Dossier

Toxicological information

Dermal absorption

Currently viewing:

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
human
Sex:
male
Details on test animals 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
- Area of exposure: forearm

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 urine 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

Any other information on results incl. tables

- The absorption rate of [14C]2,4 -TDA in human skin was 23.7 ± 16.1% of the dose during 24 h, as extrapolated by the amount of radiotracer (14C) found in the urine over a 5-day period.

- The peak urinary excretion was between 4 -8 h after application of the dose.

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

Men [% of the dose excreted]
0-4 h 1.1
4-8 h 4.7
8-12 h 3.6
12- 24 h 11
24 - 48 h 2.4
48 -72 h 0.4
72 -96 h 0.3
Recovery 23.5

- the excretion table was wrongly labeled in the study summary.

Applicant's summary and conclusion