Registration Dossier
Registration Dossier
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EC number: 601-017-1 | CAS number: 110964-79-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-01-17 to 1996-01-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- based on Kimber I, Dearman RJ, Scholes EW and Basketter DA (1994). The Local Lymph Node Assay: Developments and Applications. Toxicology, 93, 13-31.
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-methanesulfonyl-2-nitrobenzoic acid
- EC Number:
- 601-017-1
- Cas Number:
- 110964-79-9
- Molecular formula:
- C8 H7 N1 O6 S1
- IUPAC Name:
- 4-methanesulfonyl-2-nitrobenzoic acid
- Details on test material:
- - Name of test material (as cited in study report): 2-Nitro-4-methylsulfonyl benzoic acid (MNBA)
- Physical state: Solid
- Analytical purity: 97% (w/w)
- Lot/batch No.: 15483-30-1
- Storage condition of test material: Ambient temperature in darkness
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca/Ola/Hsd
- Sex:
- male
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25 µl of a 1, 3 or 10% (w/v) preparation of the test sample in DMF was applied.
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The application of hexylcinnamaldehyde at concentrations of 1, 3 and 10% (w/v) in acetone resulted in a greater than 3-fold increase in isotope incorporation at all three concentrations.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Test concentration: 0.0/1.0/3.0/10.0 Stimulation index: NA/1.66/10.14/23.26
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Test concentration: 0.0/1.0/3.0/10.0 Counts per minut: 618/1021/6244/14327
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- MNBA was a potential skin sensitiser under the conditions of the test.
- Executive summary:
A sample of MNBA was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The assay determines the level of T lymphocyte proliferation in the lymph node draining the site of chemical application, by measuring the amount of radiolabeled thymidine incorporated into the dividing cells. The test sample was applied as 1, 3 or 10% w/v preparations in dimethylformamide (DMF).
MNBA was shown to have the capacity to cause skin sensitisation when applied as 3 or 10% w/v preparations in DMF.
In a positive control study, hexylcinnamaldehyde was shown to have the capacity to cause skin sensitisation when applied as 1, 3 or 10% w/v preparations in acetone, confirming the validity of the protocol used for this study.
In conclusion, MNBA was a potential skin sensitiser under the conditions of the test.
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