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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-503-2 | CAS number: 68259-00-7
- 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:
- Initiated 11Sep2001; Reported 19Oct2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl 1-methyl-4-[(methylphenylhydrazono)methyl]pyridinium sulphate
- EC Number:
- 269-503-2
- EC Name:
- Methyl 1-methyl-4-[(methylphenylhydrazono)methyl]pyridinium sulphate
- Cas Number:
- 68259-00-7
- Molecular formula:
- C14H16N3.CH3O4S
- IUPAC Name:
- methyl 1-methyl-4-[(methylphenylhydrazono)methyl]pyridinium sulphate
- Test material form:
- solid: particulate/powder
- Details on test material:
- See study reports for batch and purity information
Constituent 1
- Specific details on test material used for the study:
- The test article, MIP 2982, Lot Number 028400A8AA (Vibracolor Yellow) (identified at receipt as MIP Yellow 2982, Batch Number 028400A8AA, Expiration Date: September 2006), was received fix)m the Sponsor on September 10,2001. The test article was received and stored under ambient conditions. Upon receipt, the test article was described as yellowish-orange powder with chunks.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test Animals
Naive, young-adult, albino Hra:(NZW)SPF rabbits were received on September 06, 2001 from Covance Research Products, Inc., a USDA-approved supplier located in Denver, Pennsylvania.
Housing
The animals were housed individually in stainless steel, screen-bottomed cages, measuring 60.7 cm X 60.3 cm x 40.7 cm (DxWxH).
Diet
The animals were presented with a measured amount of PMI* Feeds Certified Rabbit High Fiber Diet #5325 daily. Each lot of feed was analyzed by the manufacturer for concentrations of specified heavy metals, aflatoxin, chlorinated hydrocarbons, organophosphates, and specified nutrients.
Water
Water was available ad libitum throughout the acclimation and study periods. Samples of the water were analyzed by a certified laboratory approximately every 6 months for specified microorganisms and environmental contaminants.
Nutrient and Contaminant Analyses
Specified nutrient and contaminant analyses are on file at Covance - Vienna. There were no contaminants, known or reasonably anticipated, in the diet or water at levels that might interfere with the validity of this study.
Environment
Controls in the animal room were set to maintain temperatures and relative humidity of 16-22°C (61-72°F) and 50±20%, respectively, a 12-hour light/12-hour dark cycle (lights on approximately 0600 to 1800 hours), and 10 or greater air changes per hour.
Acclimation
Before being considered for study use, the animals were acclimated to laboratory conditions. After at least 5 days of acclimation, a staff veterinarian deemed them to be healthy and free from disease and physical abnormalities, and then released the animals for use in the study.
Environmental Enrichment
The animals were given plastic balls as a form of environmental enrichment.
Selection of Animals
Only healthy animals, free from skin defects or alterations in coloration or texture, were used in this study. Three rabbits (two males and one female), approximately 14 weeks old and weighing from 2328 to 2694 g, were randomly selected from the animals available for this study. Each animal was assigned a unique animal number and affixed with an ear tag marked with the corresponding animal number; the corresponding number was also affixed to the cage housing the animal.
Justification of Species Selection
Historically, the New Zealand White albino rabbit has been the animal of choice for evaluating the effects of chemicals on the skin. This species is designated by federal regulations and has a large historical database for dermal irritation assays.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- 0.5 mL distilled water
- Amount / concentration applied:
- Approximately 0.5 g of test material in a paste with 0.5mL distilled water
- Duration of treatment / exposure:
- 4-hour exposure period
- Observation period:
- Dermal irritation was evaluated at approximately 0.5 to 1, 24,48, and 72 hours after patch removal.
- Number of animals:
- Two males and one female
- Details on study design:
- Dose Administration
On the day of dosing, the test material was finely ground with a mortar and pestle and pasted with approximately 0.5 mL distilled water (Crystal Springs, Lot No. BTLD:03/20/01 LANP Exp:03/20/03) prior to application. A total of 0.5 g of the test article was applied to one intact test area (approximately 6.25 cm^) of each animal. To provide a semi-occlusive dressing, each area of exposure was covered with a gauze patch secured with paper tape, loosely overwrapped with Saran Wrap , and secured with Elastoplast tape. The animals were uncollared during the 4-hour exposure period. The dressing for each animal remained intact during the 4-hour exposure period. The adjacent, untreated skin sites of each animal served as the control.
Removal of Test Article
After a 4-hour exposure period, the dressings were removed. The residual test article was removed by spraying the treated area with tap water and soap and gently wiping with soft paper towels.
Body Weights
The animals were weighed prior to test article application.
Health and Mortality
The animals were observed twice daily (at least 4 hours apart) for general health and mortality for the duration of the study.
Reading of Dermal Irritation
Approximately 0.5 to 1,24,48, and 72 hours after patch removal, the exposure site was examined for the degree of erythema (redness) and edema (swelling). The adjacent, untreated clipped area on each animal's back was used for control. The test sites were scored according to the primary dermal irritation scoring scale (see report for details).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Other effects:
- Animals did not exhibit gross evidence of treatment-related toxicity during the course of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No findings of erythema or edema were noted in any animal at any observation period. The Primary Dermal Irritation Index (PDII) was calculated to be 0.0. No evidence of corrosion was observed. The test article is considered to be non-irritating to the skin of the rabbit under the conditions of this study.
- Executive summary:
The acute dermal irritation of the test article on rabbits under semi-occluded conditions was evaluated in general compliance with the conditions specified in the US EPA Health Effects Testing Guidelines OPPTS 870.2500 Acute Dermal Irritation (dated August 1998) and the OECD Guidelines for Testing of Chemicals, Section 4, Health Effect, No 404.
On the day of dosing, approximately 0.5 g of the test article was applied to one intact test area (approximately 6.25 cm2) on each back of three New Zealand White rabbits (two males and one female) for a 4-hour exposure period. Dermal irritation was evaluated at approximately 0.5 to 1, 24,48, and 72 hours after patch removal.
Animals did not exhibit gross evidence of treatment-related toxicity during the course of the study.
No findings of erythema or edema were noted in any animal at any observation period. The Primary Dermal Irritation Index (PDII) was calculated to be 0.0. No evidence of corrosion was observed. The test article is considered to be non-irritating to the skin of the rabbit under the conditions of this study.
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.