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EC number: 418-200-5 | CAS number: 69227-51-6
- 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:
- July 1992-December 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- and under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA study was adopted at a later stage
Test material
- Reference substance name:
- 1-ethyl-1-methylpyrrolidinium bromide
- EC Number:
- 418-200-5
- EC Name:
- 1-ethyl-1-methylpyrrolidinium bromide
- Cas Number:
- 69227-51-6
- Molecular formula:
- C7H16NBr
- IUPAC Name:
- 1-ethyl-1-methylpyrrolidin-1-ium bromide
Constituent 1
- Specific details on test material used for the study:
- 50% aqueous solution of N-methyl-N-ethyl-Pyrollidinium-Bromid
CAS # 69227-51-6
Batch # 0691
pH 6-9
Contents of quaternary compounds 49.9%
Supplier Chemson, Polymer-additive Gesellschaft m.b.H A-9601 Arnolstein
Storage at approx. 5°C in the dark
colorless liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Supplier Charles river Wiga GmbH, D-8741 Sulzfeld
Number in preliminary study 3 females
Number in main study 40 females
Body weight (gr): Control group mean 306 (-1 day) 453 (24 day); test substance group mean 306 (-1) 473 (24 day)
Animal maintenance:
Hygiene: improved hygienic condition.
Room number B3-10
Room temperature; average of 22°C
Relative humidity: average of 55%
Air exchange: 12/h
Light: artificial light from 6 a.m to 6 p.m
Cages: Makrolon cages type III (23 cm x 39 cm x 15 cm) with wire mesh lids, single caging.
Feed: Altromin standard Diet No. 3022, ad libitum.
Bedding material: wood chips (aspen) from Finn Tapvei Ky, SF-73600 Kaavi.
Water: Tap water, acidified to pH 3 with HCl, offered in Makrolon bottles with stainless steel canules, ad libitum.
Identification of animals: numbers tattooed in the pinna of the right ear.
Acclimatisation: ca. one week
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- for induction exposure of all groups
- Concentration / amount:
- 5% solution in physiological saline for intradermal induction exposure
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% undiluted
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% undiluted
- No. of animals per dose:
- to find out the appropriate concentrations for the main study 3 female guinea pigs were used. 4 different concentrations of the test substance were administered epicutaneously in the lumbar region and 4 different concentrations were applied intradermally in the interscapular region.
Intradermal injuction:
Test substance concentration: 5%, 1%, 0.1% and 0.01% in physiological saline. No lesions in the skin were noted at anyconcentration noted. therefore the highest concentration, 5% was used for the intradermal induction in the main study.
Epicutanous application:
Test substance concentrations were 100%, 30% 10% and 1%in distilled water. No adverse skin reactions could be detected at any concentration. therefore it was decided to use highest concentration (undilluted test substance) for the epicutaneous induction exposure and for challenge exposure in the main study.
main study - Details on study design:
- First induction exposure: intradermal injuctions of the test substance, of FCA (to enhance a possible sensitisation) and of the test substance diluted with FCA. Application site was an area of approx. 2 cm X 4 cm in the interscapular region.
Second induction exposure: epicutaneous application of the test substance to the sites of the intradermal injuctions.
Challenge exposure: epicutaneous application of the test substance to the left flanks and application of the vehicle to the right flanks of all animals.
Skin reactions of the challenge exposure were recorded. Positive skin reactions of the test substance treated sites indicate a sensitising effect of the test substance, if the scores are higher than those of the vehicle treated sites and if the rate of those-positively reacting-animals is higher than the corresponding percentage of animals in the negative control group.
main test: 20 females, intradermal exposure, test substance 5% in physiological saline; epicutaneous exposure, test substance undiluted (100%); Challenge exposure, left flank , test substance, undiluted (100%), right flank distilled water. - Challenge controls:
- negative control, left flank test substance, undiluted (100%); right flank distilled water 20 females
- Positive control substance(s):
- yes
- Remarks:
- 1,4-phenylenediamine
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: mortality
- Group:
- other: all animals
- Dose level:
- all doses
- Clinical observations:
- all animals survived till end of the study
- Remarks on result:
- other: no mortality
- Reading:
- other: Body weight
- Group:
- other: all animals
- Dose level:
- all doses
- Clinical observations:
- Body weight gain was within normal range in all groups.
- Remarks on result:
- other: no effect on body gain
- Reading:
- other: General observations
- Group:
- other: epicutaneous exposure (induction, challenge)
- Clinical observations:
- immediately after the begining of all epicutaneous exposures (induction, challenge) the motor activities of all animals were increased. this is due to the dressings which restrict the freedom of movement. Soon afterwards the behaviour was regular again.
- Remarks on result:
- other: motor activity was back to normal
- Key result
- Reading:
- other: skin reaction after intradermal induction exposure
- Group:
- test chemical
- Clinical observations:
- local irritations observed in all animals begining on the day after injections. local erythema, became more severe and led to ulcerations. lesions did not heal until the end of the study. these are effects of freunds adjuvant.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Skin reaction after epicutaneous induction exposure
- Group:
- test chemical
- Clinical observations:
- All animals of all groups had severe erythema and oedema in the interscapular region, which were attributed to the adjuvant
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: after challenge exposures
- Group:
- other: control
- Clinical observations:
- control sites were normal
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: after challenge exposure
- Group:
- negative control
- Clinical observations:
- no positive reactions were noted 24 and 48 hr after challenge exposure
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: after challenge exposure
- Group:
- test chemical
- Clinical observations:
- no positive reactions were noted
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: intradermal induction, epicutanous induction exposure, epicotinous challenge exposure
- Group:
- positive control
- Dose level:
- 0.5% in physiological saline for intradermal induction; 25% in white petrolium for epicutanous induction exposure, 10% in w. petrolium for epicotinous challenge exposure
- Clinical observations:
- cotrol group 100% positive reaction (oedema), the treated sites were regarded as sensitized 24 and 48 hr after challenge. No positive reactions occured in control and test substance treated area of negative control
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All control sites of all animals were without positive skin reaction
In both control groups all test substance treated sites were normal after challenge exposure.
According to the scheme of Magnusson and Klingman, atest substance is graded as "weakly sensitising" in the guinea pig maximisation test if 0-8% of the treated animals show a positive effect.
Therefore the test substance is classified as weakly sensitising agent when applied as a 5% solution for intradermal induction exposure and undiluted (100%) for epicutaneous induction and challenge exposure. - Executive summary:
Maximisation test according to Magnusson and kligman (OECD 406) was conducted on guinea pigs in order to reveal a possible sensitising potential of 50% aqueous solution of N-Methyl-N-Ethyl-Pyrollidinium-Bromid (MEP).
20 female guinea pigs were used as test substance group and 20 as negative controls.
there were 2 induction exposures (intradermally and epicutaneously) and one epicutaneous challenge exposure. The test substance concentrations were 5% in physiological saline for intradermal induction and 100% (undiluted) for epicutaneous induction and challenge exposures.
Application of Freunds adjuvant was included in the intradermal exposure of both groups to enhance possible sensitisation.
All animals survived till the end of the study. Intradermal injections of Freunds adjuvant caused severe local reactions in all animals (a known effect of the adjuvant). Sensitisation exccluded, no other adverse effects were noted.
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