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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Description of key information
Skin:
A 50% aqueous solution of the test substance was applied to intact skin of each of 3 rabbits.
Study was conducted according to OECD 404 and EC guideline 84/449 (method B4).
the animals were exposed for 4 hr and observations were done after 24, 48 and 72 hr after the end of exposure.
No toxic effects were noted. In animal 302 (#2) very slight erythema formation
Eye:
Mean scores for observations of the cornea, the iris and also for redness and for chemosis of the conjunctiva were "0" i.e normal in all animals
No general toxic effects were observed.
Therefore a 50% aqueous solution of the test substance is not irritant to eyes
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July-November 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP and OECD guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Chemical nature: 50% aqueous solution of the test substance
Cas # 69227-51-6
Batch # 0691
pH: 6-9
Storage: 5°C in the dark
Supplier: Chemson, Polymer- additive Gesellschaft m.b.H. A-9601 Arnoldstein
Appearance: colourless liqiud - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- SOURCE ANIMAL
- Source: Charles River Wiga GmbH, Sandhofer Weg 7 D-8741 Sulzfeld
- Sex: 3 females
- Age at study initiation (in days): not mentioned
- Weight at study initiation: N0 310, 302, 303: 2.3 kg each
- Housing: individual caging in metal wire cages
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum.
- Water (e.g. ad libitum): tap water from an automatical watering system, ad libitum
- Acclimation period: 5 days - Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 50% aqueous solution of the test substance was applied to the intact skin of each of 3 rabbits.
- Duration of treatment / exposure:
- exposure 4 hr
- Observation period:
- 0, 24, 48 and 72 hr after end of exposure
- Number of animals:
- 3 females
- Details on study design:
- Hair was clipped on the dorsal area of the trunk one day before the application of the test substance. An electric hair clipper, was used. The test site was median on the dorsal thoracal region. A cellulose patch with 0.5 gr of test substance spread over an area of approx. 6 cm2 was applied to the test site and held in place byfixing marginally with non irritating tape. The application site was prevented by a plastic collar. The duration of exposure was 4 hr. At the end of the exposure period the dressing, the tape with the patch and the collar were removed. residual test substance was wiped off using wet cellulose tissue.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1, 2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Scores of 0 were noted at first skin observation for erythema formation and for oedema formation in all animals.
scores at reading times (24, 48 and 72 hr after the end of the exposure):
Erythema and eschar formation: only scores of 0, i.e normal scores, were observed in 2/3 animals at each reading time. In animal 302 (#2) very slight erythema formation (score 1) was noted 24 hr after exposure.
Oedema formation: In all animals only scores of 0, i/e normal scores, were noted at reading times.
- Other effects:
- No additional effects were noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 50% aqueous solution of the test substance is not skin irritant
- Executive summary:
A 50% aqueous solution of the test substance was applied to intact skin of each of 3 rabbits.
Study was conducted according to OECD 404 and EC guideline 84/449 (method B4).
the animals were exposed for 4 hr and observations were done after 24, 48 and 72 hr after the end of exposure.
No toxic effects were noted. In animal 302 (#2) very slight erythema formation (score 1) was noted 24 hr after exposure which was reversible.
Based on the study results, the test substance was found to be non irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 October - 27 October 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- N-Methyl-N-Ethyl-Pyrollidinium-bromid
50% aqueous solution
Cas # 69227-51-6
Batch # 0691
pH 6-9
Storage 5°C in the dark
Supplier: Chemson, Polymer-additive Gesellschaft m.b.H.
A-9601 Arnoldstein
Colorless liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Supplier: Charles River Wiga GmBH, Sandhofer Weg 7, D-8741 Sulzfeld
number and sex: 3 females
body weight (on day of application):
animal No. 101: 2.6 kg; 102: 2.7 kg; 103 2.7 kg
Animal maintenance:
Hygiene: improved conventional conditions
Room number: PHA 16
Room temperature: average of 20°C
Relative humidity: average of 55%
Air exchange: 12/h
Light: artificial light from 6 am to 6 pm
Cages: individual caging in metal wire cages. Ehret Gmbh, D-7830 Emmendingen, type KK 016R, 79 X 59 cm X 35 cm.
Feed: Altromin 2023 diet for rabbits, ad libitum. Random samples of the food are analysed for contaminants by Altromin, D-4977 Lage.
Water: tap water from an automatical system, ad libitum.
Identification: labelling with felt-tipped pen in the ear.
Acclimatization: 12 days (animal No. 101) and 19 days (animals No. 102 and No. 103), respectively. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml volume of the test substance (50% aqueous solution) was applied
- Duration of treatment / exposure:
- After application the eye was held closed for about 1 sec to prevent loss of test substance. the left eye was served as control
- Observation period (in vivo):
- Both eyes were examined within 24 hr before application and approx. 1, 24, 48 and 72 p.a. The entire eye, especially
- Number of animals or in vitro replicates:
- The test substance was applied first to one animal. Since there was no risk of serious damage to the eye of this animal noted after reading times, the test substance was applied to the other two animals to.
- Details on study design:
- The entire eye, especially cornea, iris and conjunctivae were examined, using an otoscope-lamp. Eye irritation /corrosion was scored.
According to the EC-guideline 91/325 a test substance is classified as irritant to the eye, if in 2/3 animals one of the following mean scores is obtained:
Cornea: 2 to <3
Iris: 1 to < 2
Conjuctiva, redness: 2.5 or more
Conjunctiva, chemosis: 2 or more - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1/24/48/72 hr
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1/24/48/72 hr
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis and redness
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1/24/48/72hr
- Score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mean scores for observations of the cornea, the iris and also for redness and for chemosis of the conjunctiva were "0" i.e normal in all animals
No general toxic effects were observed.
Therefore a 50% aqueous solution of the test substance is not irritant to eyes - Executive summary:
0.1 ml of a 50% aqueous solution of the test substance was applied to the cojunctival sac of one eye of each of 3 rabbits.
OECD 405 was applied, and observetions were made 1, 24 48 and 72 hr p.a
Mean scores for observations of the cornea, the iris and also for redness and for chemosis of the conjunctiva were "0" i.e normal in all animals
No general toxic effects were observed.
Therefore a 50% aqueous solution of the test substance is not irritant to eyes
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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.