Registration Dossier
Registration Dossier
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: 629-716-7 | CAS number: 1211950-04-7
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Nov - 25 Nov 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No full product composition given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride
- EC Number:
- 629-716-7
- Cas Number:
- 1211950-04-7
- Molecular formula:
- No molecular formula
- IUPAC Name:
- N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride
- Test material form:
- liquid
- Details on test material:
- - Chemical name : N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride
- EC number : 629-716-7
“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number of animals: One male New Zealand White rabbit was used.
Acclimation: at least 5 days before the beginning of the study.
Weight: on the day of treatment, the animal had a body weight 2.5 kg.
Identification: individual metal ear tag.
Environmental conditions: under continuous control and recording.
. temperature: 18±3°C
. relative humidity: 30 to 70%
. lightldark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The animal was housed individually in polystyrene cage (48.2 cm x 58 cm x 36.5 cm).
The cage was equipped with a food container and a water bottle.
During the study, the animal had free access to 112 C pelleted diet (UAR, 91360 Villemoissonsur-Orge, France).
Each batch of food is analysed by the supplier for composition and contaminant levels. (appendix to report)
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories.
DEVIATION FORM PROTOCOL:
. the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the protocol.
This minor deviation was not considered to compromise the validity or integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped using electric clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml placed on a dry gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animal. The pad was held in place by adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
- Duration of treatment / exposure:
- 3 minutes and 4 hours
After removal of the dressing, any residual test substance was wiped off by means of a moistened gauze pad. - Observation period:
- 1 hour, 24, 48 and 72 hours after removal of the dressing.
When there was persistent cutaneous irritation after 72 hours, the observation period was extended to a maximum of 14 days (until day 15) in order to determine the progress of the lesions and their reversibility. - Number of animals:
- 1
- Details on study design:
- The untreated skin served as control.
Any change in the animal's behaviour was noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 3 minute exposure
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score 4 on day 8 when killed for ethical reason.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 3 minute exposure
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score 4 on day 8 when killed for ethical reason.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 4 hr exposure
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score 4 on day 8 when killed for ethical reason.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 4 hr exposure
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score 4 on day 8 when killed for ethical reason.
- Irritant / corrosive response data:
- After a 3-minute or 4-hour exposure, a moderate to severe erythema (grade 3 or 4) and a slight to severe oedema (grade 2 or 4) were observed between day 2 and day 8; crusts were recorded from day 3 or day 5 and cutaneous necrosis was noted on day 8. The animal was then killed on day 8 for ethical reason.
Mean scores over 24, 48 and 72 hours for the animal after a 4-hour exposure were 3.0 for erythema and 2.0 for oedema. - Other effects:
- no data.
Any other information on results incl. tables
Scoring dermal irritation:
1h | 24h | 48h | 72h | Mean | |||||||
rabbit | day | 1 | 2 | 3 | 4 | 24/48/72 | 5 | 6 | 7 | 8 | |
3 min | #1 | Erythema | 2 | 3 | 3 | 3 | 3,0 | 4 | 4 | 4 | 4 |
Oedema | 0 | 2 | 2 | 2 | 2,0 | 2 | 2 | 2 | 4 | ||
Other | |||||||||||
4-hrs | #1 | Erythema | 2 | 3 | 3 | 3 | 3,0 | 4 | 4 | 4 | 4 |
Oedema | 2 | 2 | 2 | 2 | 2,0 | 2 | 2 | 2 | 4 | ||
Other | A | A | A | A | A | N |
A = Crust
N = Necrosis
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Signs of necrosis became apparent after 8 days observation following 3 minutes exposure.
Therefore, the test substance STABIRAM MS6 is corrosive when applied topically to rabbits. GHS Cat. 1B. - Executive summary:
Stabiram MS6 was tested under GLP according to OECD 404.
0.5 ml was dermally applied to the clipped skin of one rabbits under semi-occusive conditions for 3 minutes and 4 hours. Following both exposure durations the mean score for erythema and edema at 24, 48 and 72 hours after patch removal were 3.0 for erythema and 2.0 for edema. Also following both exposures necrosis was noted on day 8.
Therefore Stabiram MS6 should be classified according to GHS as: Corrosive (Category 1B).
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.
