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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
In vitro study of the percutaneous absorption of four aromatic amines using hairless rat skin
Author:
Levillain, F et al.
Year:
1998
Bibliographic source:
Xenobiotika, 48(2): 948-951

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
yes
Remarks:
; just one concentration tested, no reference substance tested
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
106-76-1
IUPAC Name:
106-76-1
Constituent 2
Chemical structure
Reference substance name:
4-chloroaniline
EC Number:
203-401-0
EC Name:
4-chloroaniline
Cas Number:
106-47-8
Molecular formula:
C6H6ClN
IUPAC Name:
4-chloroaniline
Constituent 3
Reference substance name:
4-dichloroaniline
IUPAC Name:
4-dichloroaniline
Details on test material:
- Name of test material: parachloroaniline
- Analytical purity: < 98%
Radiolabelling:
no

Test animals

Species:
rat
Strain:
other: hairless SPF mutant rats
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IFFA Credo (L'Arbresle, France)
- Age at study initiation: 10 weeks
-housing: no

Administration / exposure

Type of coverage:
open
Vehicle:
other: monochlorobenzene
Duration of exposure:
24 h
Doses:
- Nominal doses: 200 mg/ mL (20 % (w/v))
- Actual doses: 2 mg / cm²
- Actual doses calculated as follows: 200 (µg/µL)* 20 µL / 2 cm²
- Dose volume: 20 µL
No. of animals per group:
4
Details on study design:
no data
Details on in vitro test system (if applicable):
SKIN PREPARATION
- Source of skin: hairless SPF mutant rats
- Type of skin: dorsal area
- Preparative technique: cervical fracture, skin taken, excess fat and connective tissue removed



PRINCIPLES OF ASSAY
- Diffusion cell: Franz-Cell
- Receptor fluid: 0.9% saline solution with antibiotics
- Static system: with stirring
- Test temperature: 32 °C
- Occlusion: no
- Reference substance(s): no

Results and discussion

Signs and symptoms of toxicity:
not specified
Remarks:
in vitro
Dermal irritation:
not specified
Remarks:
in vitro
Absorption in different matrices:
no data
Total recovery:
52.5 +/- 7.7 % of applied dose
Conversion factor human vs. animal skin:
human skin is less permeable than rat skin

Any other information on results incl. tables

t 1/2 (h)= 1.23 +/- 0.20;

absorption rate constant (per h)= 0.07 +/- 0.001;

permeability constant ((cm/h)* 0.001)= 2.14 +/- 0.34

4-chloroaniline was found to penetrate the skin

Applicant's summary and conclusion

Executive summary:

Levillain F (1998)

The aim of this study was to estimate the rate of dermal absorption of p-chloroaniline in vitro. Therefore dorsal skin of nude female SPF rats was clamped over a Franz difussion cell, where epidermal side was exposed to the ambient and the dermal side to constantly stirred saline solution. The epidermal side was treated with 2 mg/cm² 4-dichloroaniline (20 % in Chlorobenzene) and the absorption through the skin was determined by calculating the amount of 4-dichloroaniline in the saline solution over time.

t 1/2 (h)= 1.23 +/- 0.20;

absorption rate constant (per h)= 0.07 +/- 0.001;

permeability constant ((cm/h)* 0.001)= 2.14 +/- 0.34

4 -chloroaniline was found to penetrate the skin