Registration Dossier
Registration Dossier
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EC number: 203-419-9 | CAS number: 106-65-0
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Dimethyl succinate
- EC Number:
- 203-419-9
- EC Name:
- Dimethyl succinate
- Cas Number:
- 106-65-0
- Molecular formula:
- C6H10O4
- IUPAC Name:
- dimethyl succinate
- Details on test material:
- - Name of test material (as cited in study report): Dimethylsuccinate
- Physical state: Liquid
- Lot/batch No.: ETMS101
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature, proteced from light
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH
- Age at study initiation: 8 weeks
- Weight at study initiation: 18.2 - 21.5 g
- Housing: Individually in Makrolon type II cages
- Diet (e.g. ad libitum): Altromen 1324forte, ad-libitum
- Water (e.g. ad libitum): Tap water, ad-libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0deg C average
- Humidity (%): 46.1% average
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hpours dark
IN-LIFE DATES: From: 2004-04-19 To: 2004-04-27
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Low dose: 25% (v/v)
Mid dose 50% (v/v)
High dose: 100% (undiluted) - No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: Minor increase in ear thickness, within the normal range
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA pooled lymph node method
- Criteria used to consider a positive response: 3 fold increase in stimulation index
TREATMENT PREPARATION AND ADMINISTRATION:
The substance was used undiluted or dissolved in dimethylformamide and administered to 3 groups of 5 female CBA/Ca mice. Administration was epicutaneous to the dorsal surface of both ears, once a day on 3 consecutive days. The volume administered was 25 μL per ear.
Two groups with 5 animals each served as positive and negative controls. Both control substances were administered under the same conditions as the test substance. The following solutions served as control substances:
- Positive control: 25% (v/v) solution of hexyl cinnamic aldehyde in acetone:olive oil (4:1, v/v)
- Negative control: Dimethylformamide
Five days after the first topical application, 3H-thymidine was intravenously administered to all mice via the tail vein. Approximately 5 hours later all animals were sacrificed, the draining auricular lymph nodes were excised, pooled for each group, and single cell suspensions were prepared. Incorporation of 3H-methyl thymidine into the cells was determined by liquid scintillation counter and compared with the negative controls.
The stimulation index (SI) was calculated as the ratio of the disintegrations per minute (dpm) of the dosed groups or of the positive control group relative to the dpm of the negative control group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- SI - 25.4 (Positive)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- Low dose - 25%
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- Mid dose - 50%
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- High dose - 100%
- Parameter:
- SI
- Value:
- 25.4
- Test group / Remarks:
- Positive control - 25%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance does not act as a skin sensitiser
- Executive summary:
A Local Lymph Node Assay has been performed to evaluate potential dermal sensitization using mthods described in OECD Test Guideline No. 429. Dimethyl succinate does not act as a skin sensitiser
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