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Diss Factsheets
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EC number: 259-563-8 | CAS number: 55281-26-0
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Source study has reliability 2. Details on read across approach are attached in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- Test carried out according to method given in "Hazardous substances regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (Feb 1965).
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 - 16 weeks
- Weight at study initiation: 3.04 kg (M), 2.38 kg (F)
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Humidity: 50 - 70 %
- Photoperiod: 15 h light - 9 h dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- intact and abraded
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 10 g of the test compound was dissolved in 10 ml water, to make a solution of approximately 15 ml volume. 0.75 ml of the solution was applied to each test site on a 2.5 cm square gauze pad.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6 (3 M and 3 F)
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.
- Application: 0.75 ml of the solution was applied to each test site on a 2.5 cm square gauze pad. These were covered with aluminium foil secured with "Sleek"*- adhesive tape. Test sites were then enclosed by a self adhesive bandage, the edges of which were fixed to the skin by strips of "Sleek" in order to retain test substance in close contact with the skin.
REMOVAL OF TEST SUBSTANCE
- Washing: no
OBSERVATION TIME POINTS
After 24 hours, dressing was removed and intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours.
SCORING SYSTEM:
Erythema and eschar formation
0 No erythema
1 Slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beef red) to slight eschar formation
Oedema formation
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3 ,#4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other:
- Remarks:
- no scoring at 48 h; 48 h score assumed to be equal to the highest score between 24 and 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
erythema | oedema | ||||||
intact | abraded | intact | abraded | ||||
24 h | 72 h | 24 h | 72 h | 24 h | 72 h | 24 h | 72 h |
0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to the rabbit skin.
- Executive summary:
Method
Skin irritation study in 6 rabbits, shaved on left and right flank. Test substance was applied on both flanks (one intact and one abraded) for 24 h under occlusive dressing. Scoring for erythema and oedema formation was done at 24 h and 72 h after start of application.
Results
Mild signs of erythema were noted at 24 h in 2/6 and 3/6 rabbits on intact and abraded skin, respectively. Such signs were no more present at the 72 h observation time point. No signs of oedema were noted.
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