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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-05-15 to 1985-05-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Please refer to the supporting study de Jong, 2005.
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:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White (Bor: DHPW)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 6-9 weeks
- Weight at study initiation: 344-485 g
- Housing: single housing makrolon cage, type III
- Diet: standard diet ad libitum (ALTROMIN(R) Nr. 3022 from Altromin, Lage, Germany)
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 55 +/- 15 %
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: Intradermal (Day 1), Epidermal (Day 8)
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction:
Intrademal 30 %
Epidermal: paste (0.5 g test substance with 0.4 ml physiol. saline)
Challenge: 50 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction:
Intrademal 30 %
Epidermal: paste (0.5 g test substance with 0.4 ml physiol. saline)
Challenge: 50 %
- No. of animals per dose:
- control group: 10
test group: 20 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Introdermal
- No. of exposures: 6 (2 x test substance, 2 x test substance / FCA (1:1), 2x FCA)
- Exposure period: Day 1
- Test groups: test group: see above
- Control group: same treatment, but vehicle instead of test substance
- Site: shoulder region
- Frequency of applications: once on day 1
- Duration: single exposure, next exposure on day 8
- Concentrations: 30 %
Epidermal
- No. of exposures: 1
- Exposure period: Day 8
- Test groups: occlusive patch with test substance: paste (0.5 g test substance with 0.4 ml physiol. saline)
- Control group: same treatment, but vehicle instead of test substance
- Site: shoulder region
- Frequency of applications: once on day 8
- Duration: 48 h
- Concentrations: paste (0.5 g test substance with 0.4 ml physiol. saline)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 22, day 23
- Exposure period: 24 h
- Test groups: right flank (vehicle), left flank (test substance)
- Control group: same as test group
- Site: flank
- Concentrations: 50 %
- Evaluation (hr after challenge): 24 and 48 hrs after last challenge - Challenge controls:
- yes (see details on study design)
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no positive control
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- not tested
- Clinical observations:
- not tested
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- not tested
- Clinical observations:
- not tested
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Methenamine is sensitising in the guinea pig maximation test.
- Executive summary:
In a dermal sensitization study (GPMT) with methenamine (> 99 %) in physiological saline 6-9 weeks old female Pirbright White guinea gigs were tested using the method of Magnusson and Kligman.
No clinical signs were noted. After intradermal (30 %) and epidermal induction (paste: 0.5 g test substance in 0.4 ml physiol. saline) and challenge (50 %) 15 out of 20 animals showed etythema and edema 24 and 48 h after the last challenge. In the negative control group none of the 10 animals tested showed signs of sensitisation.
In this study, methenamine is a dermal sensitizer.
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