Potassium dimethyldithiocarbamate

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance zinc(bis) dimethyldithiocarbamate (CAS No. 137-30-4). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on an read-across substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 428 (Skin Absorption: In Vitro Method)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ziram

EC Number:

205-288-3

EC Name:

Ziram

Cas Number:

137-30-4

IUPAC Name:

zinc bis(dimethyldithiocarbamate)

Constituent 2

Reference substance name:

zinc bis dimethyldithiocarbamate

IUPAC Name:

zinc bis dimethyldithiocarbamate

Details on test material:

- Name of test material (as cited in study report): Ziram

Non-labelled compound:
- Lot no.: 9106-4716/29 (analytical grade), G4A0051877 (technical grade)
- Purity: 97.1% (analytical grade), 98.8% (technical grade)

Labelled comppund:
- Lot no.: XV/36
- Purity: 98% (radiochemical)

Radiolabelling:

yes

Remarks:

[methyl-14C]-Ziram

Test animals

Species:

human

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Duration of exposure:

6h

Doses:

1.55, 643 mg/mL

No. of animals per group:

4-6 diffusion cells per dose

Control animals:

no

Details on in vitro test system (if applicable):

SKIN PREPARATION
- Source of skin: Full-thickness human skin samples (3 abdomen) were obtained post-mortem from two females and one male aged 24 to 64 years old.
- Thickness of skin (in mm): 200-400 µm
- Membrane integrity check: Yes

PRINCIPLES OF ASSAY
- Receptor fluid: 0.01 M phosphate-buffered saline, supplemented with 5% w/v bovine serum albumin, adjusted to pH 7.4 was used as the receptor fluid for the barrier integrity assessment and Ziram permeability assessment.

- Specific activity of test substance: 11.3 MBq/mg (= 305.4 µCi/mg)
- Volume applied: 6.4 µl of each preparation (per 0.64 cm²)
- Sampling time: Receptor fluid: in hourly fractions for the duration of the experiment (24 h).
Tape strips, remaining receptor fluid and washings: at study termination (24 h).

Results and discussion

Absorption in different matrices:

see Table 6_2-1

Total recovery:

see Table 6_2-1

Any other information on results incl. tables

Table A6_2-1       Table for in vitro percutaneous absorption study in human skin (mean of 4-6 values)
	Distribution of Radioactivity (% Applied Dose)
Samples	1.55 mg/mL	643 mg/mL
1.         Receptor fluid (0-24 h)	0.38	0.02
2.         Receptor fluid at termination	0.01	nd
3.         Skin	nd	nd
4.         Receptor chamber	nd	nd
5.         Tape (stratum corneum)	1.84	0.04
6.         Total absorbed (1+2+3+4+5)	2.23	0.06
7.         Skin swab (after 6 h)	87.82	93.95
8.         Tape (surface)	1.49	0.11
9.         Donor chamber	0.21	nd
10.      Total non-absorbed (7+8+9)	89.52	94.06
11.      Total recovery (6+10)	91.75	94.12