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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
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 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dimethyldithiocarbamate
EC Number:
204-876-7
EC Name:
Sodium dimethyldithiocarbamate
Cas Number:
128-04-1
Molecular formula:
C3H7NS2.Na
IUPAC Name:
sodium dimethyldithiocarbamate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 360-446 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
shown in details
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
shown in details
No. of animals per dose:
10 (control group: 5)
Details on study design:
PILOT STUDY
Pre-test on intradermal application on two guinea pigs with 1% and 5% SDDC.
Pre-test on topical application on two guinea pigs with 25%, 50% and 75% SDDC.


MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL
- Time Schedule: Day 0
- Exposure period: -
- Concentrations: 5%
- Volume: 0.1 mL/injection site

INDUCTION EXPOSURE - EPICUTANEOUS
- Time Schedule: Day 7
- Exposure period: 48 h
- Concentrations: 50%
- Volume: saturated filter paper patch (40 x 20 mm)

B. CHALLENGE EXPOSURE
- Time Schedule: Day 21
- Exposure period: 24 h
- Concentrations: 50% and 75%
- Evaluation (hr after challenge): 24 and 48 h after application

SCORING SYSTEM
0 - no reaction
0.5 - very faint erythema, usually non-confluent
1 - faint erythema usually confluent
2 - moderate erythema
3 - severe erythema with or without oedema


Challenge controls:
distilled water
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde

Results and discussion

Positive control results:
The positive control alpha-hexylcinnamaldehyde (5% in mineral oil) elicited an incidence of sensitisation of 40-50%.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
5
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 9.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
6
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 6.0. Total no. in groups: 9.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
2
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 2.0. Total no. in groups: 9.0.
Group:
positive control
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Table 7.4.1-1 Skin sensitisation scores - SDDC

Skin reactions after challenge application of 50% SDDC in distilled water (left flank)

Time point

SDDC-induced animals

Vehicle-induced animals

24 h

5/9

0/5

48 h

0/9

0/5

Skin reactions after challenge application of 75% SDDC in distilled water (right flank)

24 h

6/9

0/5

48 h

2/9

0/5

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Since the skin reactions observed at 24 h after challenge did not persist after 48 h, the proportion of truly sensitized animals is only 22%. This is not sufficient for classification as a skin sensitizer.