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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 468-740-0 | CAS number: -
- 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:
- 07 June 2005 to 05 August 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000) including the most recent partial revisions.
- GLP compliance:
- yes
Test material
- Reference substance name:
- MTDID 3285
- IUPAC Name:
- MTDID 3285
- Details on test material:
- - Name of test material (as cited in study report:MTDID 3285
- Substance type: Light brown waxy chunks
- Physical state: Solid
- Analytical purity: Minimum 86%
- Purity test date: 01 June 2006
- Lot/batch no.: Lot 30045
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other:Molecular weight: 610
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- animals of male sex
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Fasting period before study: none stated
- Housing:- Diet (e.g. ad libitum): approx 100 g/day standard laboratory rabbit diet.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-21.6 degrees C
- Humidity (%): 35-80%; higher than optimal conditions, but not considered to have an affect on study integrity
- Air changes (per hr): approximately 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent artifical light/12 hours dark
IN-LIFE DATES: From: 7 June 2005 To: 24 June 2005
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved: 150 square centimeters of the dorsal fur was clipped
- Vehicle:
- other: corn oil
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams.
- Concentration (if solution): test article only moistened with 0.4 ml vehicle.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after exposure for irritation. Toxicity was observed once daily and mortality/viability observed twice daily. Body weights were meaured prior to application on the day of treatment and at termination.
- Number of animals:
- 3 animals per sex per dose
- Details on study design:
- TEST SITE
- Area of exposure: test article applied using a metalline patch of 2 x 3 cm.
- % coverage: not stated
- Type of wrap if used: Metalline patch monted on micropore tape, which wrapped around the abdomena and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleaned using corn oil
- Time after start of exposure: 4 hours
SCORING SYSTEM: numerical scoring system assessing erythema and eschar formation (scale 0-4) and edema formation (scale 0-4)
Results and discussion
In vivo
Results
- Irritation parameter:
- other: erythema score and eschar and edema formation
- Basis:
- other: draize scoring (0-4)
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours in one animal and 72 hours in the other animals
- Remarks on result:
- other: Mean edema scores were all zero
- Irritant / corrosive response data:
- There was no evidence of a corrosive effect on the skin. Four exposure of the test article resulted in very slight or well-defined eryhtema and very slight edema in the treated skin-areas of the three rabbits.
- Other effects:
- Scores of 0 were noted for edema at 24 hours and beyond and for erythema at 72 hours. Scores of 2 for erythema were noted at 1 hour.
No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Any other information on results incl. tables
Animal |
1 (# 684) |
2 (#686) |
3 (#687) |
|||
Time after exposure |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 hour |
2 |
1 |
1 |
1 |
2 |
1 |
24 hours |
1 |
0 |
1 |
0 |
1 |
0 |
48 hours |
1 |
0 |
0 |
0 |
1 |
0 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
- Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labeling requirements for dangerous substances and preparations.
- Executive summary:
The primary skin irritation/corrosion of the test article was assessed in the rabbit (4-hour semi-occlusive application). The study was carried out based on the guidelines OECD 404, EC, Council Directive 67/548/EEC, An. V, B.4 (2004), "Acute Toxicity:Dermal Irritation/Corrosion" US EPA OPPTS 870.2500 (1998), Acute Dermal Irritation and JMAFF Guidelines (2000) including the most recent partial revisions. Three rabbits were exposed to 0.5 grams of the test article, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. Exposure to the test article resulted in very slight edema in the treated skin-areas of the rabbits, which had resolved within 48 hours after exposure in one animal and within 72 hours after exposure in the other animals. Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labeling requirements for dangerous substances and preparations.
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.