Registration Dossier
Registration Dossier
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EC number: 202-307-7 | CAS number: 94-13-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No data about GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- COMPARISON OF THE LOCAL LYMPH NODE ASSAY WITH THE GUINEA-PIG MAXIMIZATION TEST FOR THE DETECTION OF A RANGE OF CONTACT ALLERGENS
- Author:
- Basketter, D.A. and Scholes, E.W.
- Year:
- 1 992
- Bibliographic source:
- Fd Chem Toxic. Vol. 30, No. 1, pp. 65-69
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Propyl 4-hydroxybenzoate
- EC Number:
- 202-307-7
- EC Name:
- Propyl 4-hydroxybenzoate
- Cas Number:
- 94-13-3
- Molecular formula:
- C10H12O3
- IUPAC Name:
- propyl 4-hydroxybenzoate
- Details on test material:
- - Name of test material (as cited in study report): Propyl paraben
- Analytical purity: > 98%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 -12 weeks
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10 and 25%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: A chemical was regarded as a sensitizer in the LLNA if at least one concentration of the chemical resulted in a three-fold or greater increase in ³HTdR incorporation compared to the control values. Also the data had to be compatible with a biological dose response although an allowance was made, especially at high doses, for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of 4 mice were treated by a daily topical application of 25 µL of each test substance concentration on the dorsal surface of each ear for 3 consecutive days. The negative control group was treated with vehicle only. Four days after the first topical application, all mice were injected intraveniously through the tail vein with 20 µCi [³H]methyl thymidine (³HTdR) in 250 µL phosphate buffered saline (PBS). After 5 h, the mice were killed by carbon dioxide asphyxiation and the draining auricular lymph nodes were excised and pooled for each group. A single cell suspension of lymph node cells was prepared. ³HTdR incorporation was measured by β-scintillation counting. - Positive control substance(s):
- mercaptobenzothiazole (CAS No 149-30-4)
Results and discussion
- Positive control results:
- Stimulation Index:
10% positive control substance: 4.5
25% positive control substance: 4.6
50% positive control substance: 5.5
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- proliferation response test/control ratio
- Value:
- 1.3
- Test group / Remarks:
- 5% test item
- Remarks on result:
- other:
- Remarks:
- A chemical was regarded as a sensitizer in the LLNA if at least one concentration of the chemical resulted in a three-fold or greater increase in the T/C ration
- Key result
- Parameter:
- SI
- Remarks:
- proliferation response test/control ratio
- Value:
- 1.6
- Test group / Remarks:
- 10% test item
- Remarks on result:
- other:
- Remarks:
- A chemical was regarded as a sensitizer in the LLNA if at least one concentration of the chemical resulted in a three-fold or greater increase in the T/C ration
- Key result
- Parameter:
- SI
- Remarks:
- proliferation response test/control ratio
- Value:
- 1.3
- Test group / Remarks:
- 25% test item
- Remarks on result:
- other:
- Remarks:
- A chemical was regarded as a sensitizer in the LLNA if at least one concentration of the chemical resulted in a three-fold or greater increase in the T/C ration
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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