Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-905-8 | CAS number: 100-97-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.