Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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

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

Applicant's summary and conclusion