Registration Dossier
Registration Dossier
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EC number: 202-905-8 | CAS number: 100-97-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- company
- Author:
- company
- Year:
- 2 005
- Bibliographic source:
- company
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- yes different treatment protocols applied
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Methenamine
- EC Number:
- 202-905-8
- EC Name:
- Methenamine
- Cas Number:
- 100-97-0
- Molecular formula:
- C6H12N4
- IUPAC Name:
- 1,3,5,7-tetraazatricyclo[3.3.1.1³,⁷]decane
- Test material form:
- not specified
- Details on test material:
- Source: Sigma-Aldrich
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RIVM
- Age at study initiation: Young adult (6-8 weeks of age)
- Housing: macrolon cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
standard conditions
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: not applicable
- Vehicle:
- other: acetone/olive oil (4:1 v/v)
- Concentration / amount:
- 2.5, 5, 10, 20 %
Challengeopen allclose all
- Route:
- other: not applicable
- Vehicle:
- other: acetone/olive oil (4:1 v/v)
- Concentration / amount:
- 2.5, 5, 10, 20 %
- No. of animals per dose:
- not specified (probably 4 per dose, as required in OECD guideline)
- Details on study design:
- According to de Jong et al., 2002 (Toxicology 176, 123-134).
In order to enhance possible low responses of weak sensitizers animals were pretreated with sodium dodecyl sulfate 1% (SDS) on the dorsum of the ears one hour before administration.
Test 1 (Short protocol): Animals were treated on days 0-1-2 and lymph node cell proliferation was determined on day 5.
Test 2 (Repeated protocol): Animals were treated on days 0-1-2. 7-14-28-35-42-49, and 56-57-58 and lymph node cell proliferation was determined on day 61. - Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2.5, 5, 10, 20 %
- No. of animals per dose:
- not specified (probably 4 per dose, as required in OECD guideline)
- Details on study design:
- According to de Jong et al., 2002 (Toxicology 176, 123-134).
In order to enhance possible low responses of weak sensitizers animals were pretreated with sodium dodecyl sulfate 1% (SDS) on the dorsum of the ears one hour before administration.
Test 1 (Short protocol): Animals were treated on days 0-1-2 and lymph node cell proliferation was determined on day 5.
Test 2 (Repeated protocol): Animals were treated on days 0-1-2. 7-14-28-35-42-49, and 56-57-58 and lymph node cell proliferation was determined on day 61. - Positive control substance(s):
- not specified
- Statistics:
- EC3 was estimated by the benchmark approach.
Results and discussion
- Positive control results:
- no positive control.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Test 1 (Short protocol): SI = 4.0; EC2 (L05-L95) = 19.3 (11.8-53.1); EC3 (L05-L95) = 30.6 (18.7-84.2) Test 2 (Repeated protocol): SI = 5.78
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: not given.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Results of the LLNA affirm the classification of methenamine as a skin sensitizer.
- Executive summary:
In a Local Lymph Node Assay (LLNA) similar to OECD Guideline 429, an EC3 (test concentration, which causes a Stimulation Index (SI) of the auricular lymph nodes of 3.0) of 30.6% was determined for methenamine, while an EC3 as low as 0.96% was determined for formaldehyde in the same study. The test was performed treating young adult (6-8 weeks of age) female BALB/c mice with methenamine dissolved in a acetone-olive oil mixture (4:1). Test concentrations were 2.5, 5, 10 and 20%. In order to enhance possible low responses of weak sensitizers animals were pretreated with sodium dodecyl sulfate 1% (SDS) on the dorsum of the ears one hour before administration. In second test with repeated exposures the fist test was coonfirmed revealing a Stimulation Index of 5.78. Results of the LLNA affirm the classification of methenamine as a skin sensitizer.
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