Sodium dibenzyldithiocarbamate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliance OECD guideline study, no restrictions, adequate for assessment.

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 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dibenzyldithiocarbamate

EC Number:

259-587-9

EC Name:

Sodium dibenzyldithiocarbamate

Cas Number:

55310-46-8

Molecular formula:

C15H15NS2.Na

IUPAC Name:

sodium (dibenzylcarbamothioyl)sulfanide

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: 17-22 g
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 30-70% R.H.
- Air changes: 15 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs artificial fluorescent light

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

25 μl/ear of 0%, 25%, 50% and 100% in DMF (dimethylformamide) on three consecutive days

No. of animals per dose:

12 females (three groups of four females each group).
(females were nulliparous and non-pregnant).

Details on study design:

RANGE FINDING TESTS:
- Irritation: not irritant
- Lymph node proliferation response: No necropsy was performed

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Calculation of the Stimulation Index (SI). The SI is the ratio of the DPM/node/group against the DPM/node of the negative control group. If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitiser, based on the test guideline and recommendations done by ICCVAM (NIH publication; No 99-4494, February 1999).

TREATMENT PREPARATION AND ADMINISTRATION:
INDUCTION - Days 1, 2 and 3
Experimental animals:
The dorsal surface of both ears was epidermally treated with the test substance concentration, approximately the same time each day.
Vehicle control animals:
The control animals were treated the same as the experimental animals, except that, instead of the test substance, the vehicle was administered.
TREATMENT - Day 6:
All animals:
Each animal was injected via the tail vein with 0.25 ml of sterile phosphate buffered saline (PBS) containing 20 μCi of 3H-methyl thymidine (Amersham Pharmacia Biotech, NOTOX Substance 105624).
After approximately five hours, all animals were killed by intra peritoneal injection with an overdose of pentobarbital and the draining (auricular) lymph node of each ear were excised and pooled for each group in 3 ml PBS.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

No statistical analysis was performed.

Results and discussion

Positive control results:

The SI value calculated for the positive control (10% HCA in DMF) were 2.63.
Note: The SI = 2.63 value, as calculated for the 10% HCA positive control group, is relatively low, but considered sufficiently high to indicate that the assay as performed at NOTOX is able to identify possible skin sensitisers.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: The SI values calculated for the test substance concentrations 25%, 50% and 100% were 0.77, 0.47 and 0.53 respectively. The results are applicable for 16.9% aqueous solution of the substance.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: DPM/node values for the experimental groups treated with test substance concentrations of 25%, 50% and 100% were 217, 133 and 148 respectively. The DPM/node value for the vehicle control group was 281.

Any other information on results incl. tables

RADIOACTIVITY MEASUREMENTS

GROUP#	INDUCTION	NODES	DPM/GROUP	DPM/NODE
1	Vehicle Control (DMF*)	8	2244	281
2	25% test substance in DMF	8	1733	217
3	50% test substance in DMF	8	1060	133
4	100% test substance	8	1179	148

#. Four females each group

*. Vehicle: Dimethylformamide.