Registration Dossier
Registration Dossier
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EC number: 619-599-0 | CAS number: 915095-94-2
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: Guideline study (OECD 429) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- (3S)-3-{4-[(2-chloro-5-iodophenyl)methyl]phenoxy}oxolane
- EC Number:
- 619-599-0
- Cas Number:
- 915095-94-2
- Molecular formula:
- C17 H16 Cl I O2
- IUPAC Name:
- (3S)-3-{4-[(2-chloro-5-iodophenyl)methyl]phenoxy}oxolane
- Reference substance name:
- (S)-3-[4-(2-Chloro-5-iodobenzyl) phenoxy] tetrahydrofuran
- Cas Number:
- 915095-94-2
- Molecular formula:
- C17 H16 Cl I O2
- IUPAC Name:
- (S)-3-[4-(2-Chloro-5-iodobenzyl) phenoxy] tetrahydrofuran
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Exposure to the test article at 25, 50, 100 % (w/v) resulted in stimulation indices of 1.03, 0.92, 1.35, respectively. No statistically significant differences were observed for the mean log DPM of the groups treated with the test article when compared to the vehicle DMF group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A test material is considered to have skin sensitizing activity if, at one or more concentrations, it induces a 3-fold or greater increase in proliferative activity relative to the concurrent vehicle treated control group. Thus, a stimulation index (SI) ≥ 3.0 is regarded as a positive response. Although the dosing solution concentrations were not verified, treatment with IN 00078283 at nominal concentrations up to 100% did not result in an SI of 3 or greater.
Therefore, based on the data from this study, IN 00078283 is not considered to have skin sensitizing potential.
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