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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Version / remarks:
(1996)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-290-0
EC Name:
-
Cas Number:
3380-30-1
Molecular formula:
C12 H8 Cl2 O2
IUPAC Name:
5-chloro-2-(4-chlorophenoxy)phenol
Details on test material:
- Name of test material (as cited in study report): FAT 80'220/B = DCPP
- Physical state: White emulsion
- Analytical purity: 0.3% DCPP (w/v)
- Lot/batch No.: 98/06/03
Radiolabelling:
no

Test animals

Species:
pig
Strain:
other: not applicable
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not applicable since in vitro assay using ears from adult pigs obtained from an abattoir.

Administration / exposure

Type of coverage:
other: not applicable
Vehicle:
other: DCPP was tested as O/W formulation with Tinosan® HP 100 (Tinosan® HP 100 contains 29.4% DCPP)
Duration of exposure:
0.5 and 24 h
Doses:
0.3% DCPP (w/v)
30 µg DCPP/cm² skin
No. of animals per group:
not applicable
Control animals:
no
Remarks:
, not applicable
Details on in vitro test system (if applicable):
The pig ears were washed under running water and badly damaged ears rejected. The remaining ears were shaved with animal clippers and whole skin (epidermis + dermis) was separated from the cartilage using a scalpel. The skin samples were immersed in water at 60°C for 55-60 seconds and the epidermis teased away from the dermis. Each epidermal membrane was given an identifying number and stored frozen on aluminium foil.
Discs of approximately 3.3 cm diameter of prepared skin membrane from at least three subjects were mounted, dermal side down, in diffusion cells held together with individually numbered clamps.
For determination of membrane integrity, The donor and receptor chambers of the cells were filled with physiological saline (approx 0.9% w/v sotdium chloride in water) and placed in a water bath maintained at 32 ± 1 °C.
The integrity of the membranes was determined by measurement of the electrical resistance across the skin membrane.
- Volume applied 25.4 µL
- Size of test site 2.54 cm²
- Exposure period 0.5, 24 h
- Receptor fluid 25% Ethanol in pH 7 phosphate buffered saline
- Samples Receptor fluid, tape strips, washings.
- Sampling time
- - Receptor fluid: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 h
- - Tape strips, remaining receptor fluid and washings: at study termination (24 h).


Results and discussion

Percutaneous absorptionopen allclose all
Dose:
0.3% DCPP
Parameter:
percentage
Absorption:
2 - 9 %
Remarks on result:
other: 0.5 h exposure
Remarks:
Receptor fluid: 6.22%, epidermis: 2.87%, potential absorption: 9.09%
Dose:
0.3% DCPP
Parameter:
percentage
Absorption:
15 - 34 %
Remarks on result:
other: 24 h exposure
Remarks:
Receptor fluid: 19.2%, epidermis: 15.2%, potential absorption: 34.4%

Applicant's summary and conclusion