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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
other information
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

Constituent 1
Chemical structure
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:
human
Sex:
male
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
- 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