Registration Dossier
Registration Dossier
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EC number: 700-204-6 | CAS number: 1174627-68-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 26 August 2009 to 04 November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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
- Reference substance name:
- methyl (2R)-4-(dimethylcarbamoyl)-2-methylbutanoate; methyl (2S)-4-(dimethylcarbamoyl)-2-methylbutanoate
- EC Number:
- 700-204-6
- Cas Number:
- 1174627-68-9
- Molecular formula:
- C9H17NO3
- IUPAC Name:
- methyl (2R)-4-(dimethylcarbamoyl)-2-methylbutanoate; methyl (2S)-4-(dimethylcarbamoyl)-2-methylbutanoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): DV-SOLV 1059
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J@Rj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, le Genest-St-Isle, France
- Age at study initiation: 10 weeks
- Weight at study initiation: 21.6-22.6 g
- Housing: Individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr) 15-20:
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09 September 2009 To: 15 September 2009
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 and 50%
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- HCA: 6633 DPM; S.I.: 9.4
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: Desintegration per minute
- Value:
- 1 167
- Test group / Remarks:
- DV-SOLV 1059 10% in AOO
- Parameter:
- other: Desintegration per minute
- Value:
- 1 094
- Test group / Remarks:
- DV-SOLV 1059 25% in AOO
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- DV-SOLV 1059 10% in AOO
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- DV-SOLV 1059 50% in AOO
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- DV-SOLV 1059 25 % in AOO
- Parameter:
- other: Desintegration per minute
- Value:
- 833
- Test group / Remarks:
- DV-SOLV 1059 50% in AOO
- Remarks on result:
- other:
Any other information on results incl. tables
Test Group |
Measured DPM/group |
DPM-BG |
Number of nodes |
DPN |
S.I. |
BG |
41 |
|
- |
|
|
NC |
746 |
705 |
8 |
88.1 |
1.0 |
10% in AOO |
1208 |
1167 |
8 |
145.9 |
1.7 |
25% in AOO |
1135 |
1094 |
8 |
136.8 |
1.6 |
50% in AOO |
874 |
833 |
8 |
104.1 |
1.2 |
PC |
6633 |
6592 |
8 |
824.0 |
9.4 |
BG = Background (1 ml 5% trichloroacetic acid)
NC = Negative Control Group (acetone/olive oil 4:1)
PC = Positive Control Group (25%HCA in AOO)
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item was not a skin sensitizer in this assay under the described conditions.
- Executive summary:
The test item DV-SOLV 1059 was assessed in this study for its contact allergenic potential.
A local lymph node assay was performed in CBA/J@Rj mice using test item concentrations of 10, 25 and 50% in acetone:olive oil 4:1.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. No local signs of irritation of the ear skin were detected.
In this study Stimulation Indices (S.I.) of 1.7, 1.6 and 1.2 were determined with the test item at concentrations of 10, 25 and 50% in AOO, respectively. The validity of the assay was demonstrated from the positive control substanceHCA25% in AOO, with S.I. of 9.4. The test item was not a skin sensitizer in this assay under the described conditions.
DV-SOLV 1059 is not classified as a skin sensitizer according to the criteria of Annex VI Directive 67/548/EECand EU GHS.
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