Registration Dossier
Registration Dossier
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EC number: 269-323-4 | CAS number: 68223-93-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study, GLP with certificate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Diammonium 2,2'-dithiodiacetate
- EC Number:
- 269-323-4
- EC Name:
- Diammonium 2,2'-dithiodiacetate
- Cas Number:
- 68223-93-8
- Molecular formula:
- C4H6O4S2.2H3N
- IUPAC Name:
- diammonium 2-[(carboxymethyl)disulfanyl]acetate
- Reference substance name:
- Diammonium dithiodiglycolate (DADTDG)
- IUPAC Name:
- Diammonium dithiodiglycolate (DADTDG)
- Test material form:
- other: aqueous solution 48% w/w
- Details on test material:
- Lot#: 5170
assay: 48.1 %w/w iodometric
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Source:
Age 8-12 weeks (beginning of acclimatisation)
weight 18.6 - 21.5 (beginning of acclimatisation)
3 Test groups/4 animals
1 control group
Husbandry:
Standard laboratory conditions 22+-3°C, 30-70% rel. humidity, 10-15 air changes/h
12/12 light/dark 8 hour music during light period
in groups with four macrolon type 3 cages with lignocell soft bedding
Diet: Std Kiba 3422 lot# 84/02 mouse maintenance diet ad libitum, community water (Itingen) ad libitum
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol:water 2:3 v/v
- Concentration:
- 25% , 50% and 100% undiluted
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Sensitivity and reliability of the test was assessed by use of alpha-hexylcinammaldehyd which is known for a positive reaction in CBA mice. Study RCC no. 846871 was performed betwenn Jan. 8th to Jan. 22nd, 2003.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- test material concentration: 48%
number of lymphnodes: 8
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- test material concentration: 12.5%
number of lymphnodes: 8
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- test material concentration: 24%
number of lymphnodes: 8
Applicant's summary and conclusion
- Conclusions:
- In this study stimulation indices (S.I.) of 1.0 to 1.2 were determined for the test material concentrations of 25, 50 and 100% w/v in ethanol/water 2:3 by volume.
The test material diammonium dithiodiglycolate 48% was found to be a non sensitizer (S.I. <3) when tested at concentrations up to 100% (undiluted).
Diammonium dithiodiglycolate 48% w/w causes slight to moderate skin irritation at concetration of 100% on the dorsum of the ear lobes in mice.
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