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Diss Factsheets
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EC number: 944-549-2 | 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:
- 2000.03.31 - 2000.07.04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The relative humidity in the animal holding room was consistently lower (15 %) than stated in the protocol. The sentinel rabbit assessments were conducted on Day 9 rather than Day 8. The deviations are not considered to compromise the study integrity
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The relative humidity in the animal holding room was consistently lower (15 %) than stated in the protocol. The sentinel rabbit assessments were conducted on Day 9 rather than Day 8. The deviations are not considered to compromise the study integrity
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- The relative humidity in the animal holding room was consistently lower (15 %) than stated in the protocol. The sentinel rabbit assessments were conducted on Day 9 rather than Day 8. The deviations are not considered to compromise the study integrity
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- X14DesB30
- Molecular formula:
- X14DesB30
- IUPAC Name:
- X14DesB30
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL (X14DesB30)
- Source and lot/batch No.of test material: X1YIS0201014
- Expiration date of the lot/batch: NA
- Purity 80%
- Purity test date: 2000.02.18
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: < -70 degrees Celcius
- Stability under test conditions: NA
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in vehicle (water)
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: NA
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Purified water.
- Final preparation of a solid: A 50% m/v dispersion in purified water, pH of 3.22.
FORM AS APPLIED IN THE TEST (if different from that of starting material): A 50% m/v dispersion in purified water.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rabbit (New Zealand White rabbit)
- Sex: male and female
- Age at study initiation: 11 - 13 weeks
- Weight at study initiation: 2.35 - 2.41 kg
- Housing: Single housed in floor-pens with wood chips bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 40 – 80 %
- Air changes (per hr): at least 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
IN-LIFE DATES: From: To: at least 17 days
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- 50% m/v dispersion, pH of 3.22
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL X14DesB30 as a paste - Duration of treatment / exposure:
- four hours
- Observation period:
- One hour, 24, 48 and 72 hours
- Number of animals:
- 3 (one male and two females)
- Details on study design:
- TEST SITE
- Area of exposure: 30 x 20 mm
- % coverage: NA
- Type of wrap if used: Dense elastic gauze bandage (semi-occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Light brushing and swabbing with moistened cotton wool
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) one hour, 24, 48 and 72 hours after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Petechial haemorrhage (transient - recovery after 4 days) present after removal of dose residuals.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Petechial hemorrhage (transient - recovery after 24h) present after removal of dose residuals. Developed scabs by Day 3 and showed full resolution by Day 4.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Petechial hemorrhage (transient - recovery after 24h) present after removal of dose residuals. Developed scabs by Day 3 and showed full resolution by Day 4.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Petechial haemorrhage (transient - recovery after 4 days) present after removal of dose residuals.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Petechial hemorrhage (transient - recovery after 24h) present after removal of dose residuals. Developed scabs by Day 3 and showed full resolution by Day 4.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1/24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Petechial hemorrhage (transient - recovery after 24h) present after removal of dose residuals. Developed scabs by Day 3 and showed full resolution by Day 4.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Study was conducted to determine the irritation caused to intact rabbit skin following a single (4 hour), semi-occluded, topical application of X14DesB30. The study was designed in accordance with OECD guideline method 404. One male and two female rabbits were exposed to a single dose of 0.5 mL X14DesB30 applied to a 30 x 20 mm area on the clipped dorsum. All animals were killed by an intravenous injection of an overdose of barbiturate at day 4. X14DesB30 did not cause any notable dermal reactions. All observed reactions were a result of mechanical trauma caused by removal of the dose residuals.
- Executive summary:
The Study was conducted to determine the irritation caused to intact rabbit skin following a single (4 hour), semi-occluded, topical application of X14DesB30. The study was designed in accordance with OECD guideline method 404, the commission directive 92/69/EEC, Method B4, and the US EPA Health effects test Guidelines OPPTS 870.2500. A single dose of 0.5 mL X14DesB30 was applied to a 30 x 20 mm area on the clipped dorsum of each of three rabbits, one male and two female rabbits. A semi- occlusive bandage covered the treated area of skin for 4 hours and dermal reactions to treatment were assessed for up to nine days after removal of the dressings. All animals were killed by an intravenous injection of an overdose of barbiturate at Day four or Day nine. Transient petechial hemorrhage was observed as a result of mechanical trauma caused by removal of the dose residuals. Summarized, X14DesB30 did not cause any notable dermal reactions and classified not to cause skin irritation.
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