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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: Well performed GLP study according to OECD TG.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
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

Constituent 1
Chemical structure
Reference substance name:
m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid
EC Number:
204-303-0
EC Name:
m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid
Cas Number:
119-17-5
Molecular formula:
C10H10N2O4S
IUPAC Name:
3-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): Pyrazolic acid 3 TF

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
- Test system: Mice, CBA/CaOlaHsd
- Rationale: Recognised as the recommended test system
- Source: Harlan Netherlands
- Age: 7 - 8 weeks (beginning of acclimatisation)
- Identification: Single caging. The animals were distributed into the test groups at random and identified by cage number.
- Acclimatisation: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
- Housing: single
- Cage Type: Makrolon Type I, with wire mesh top
- Bedding: granulated soft wood bedding
- Feed: pelleted standard diet, ad libitum
- Water: tap water, ad libitum,
- Temperature: 22 +/- 3°C
- Relative humidity: 30-78%
- Artificial light: 6.00 a.m. - 6.00 p.m.

Study design: in vivo (LLNA)

Vehicle:
other: ethanol : deionised water (70:30)
Concentration:
Group 1: Control (Vecicle)
Group 2: 6.25%
Group 3: 12.5%
Group 4: 25%
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
The mean values and standard deviations were calculated for body weights.

Results and discussion

Positive control results:
EC3 = 6.7% (w/v)

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Group 1 (Control): - Group 2 (6.25%): 1.15 Group 3 (12.5%): 0.77 Group 4 (25%): 0.76
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
DPM per lymph node: Group 1 (Control): 406.1 Group 2 (6.25%): 466.4 Group 3 (12.5%): 311.3 Group 4 (25%): 307.5 Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled

Any other information on results incl. tables

The EC3 value could not be calculated, since all SI's are below 3.

 

Viability / Mortality

No deaths occurred during the study period.

Clinical Signs

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.

Body Weights

The body weight of the animals, recorded prior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.


Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test item Pyracolic acid 3 TF was found to be not a skin sensitiser under the described conditions.
Executive summary:

In this study the test item Pyrazolic acid 3 TF suspended in ethanol:deionised water (70+30) was assessed for its possible contact allergenic potential.

For this purpose a local lymph node assay was performed according to OECD guideline 429 using test item concentrations of 6.25, 12.5, and 25%.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.

In this study Stimulation Indices (S.I.) of 1.15, 0.77, and 0.76 were determined with the test item at concentrations of 6.25, 12.5, and 25% in ethanol:deionised water (70:30), respectively.

The test item Pyrazolic acid 3 TF was found not to be a skin sensitiser in this assay.