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EC number: 602-997-3 | CAS number: 124495-18-7
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Methods Number B.2 Acute Toxicity (Dermal)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Acute Dermal Toxicity Study
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 124495-18-7
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Substance ID: TSN 100097
- Name of substance: XDE-795
- Lot number: DECO-97-152-1
- Purity: 97.4%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan
- Age at study initiation: Approximately 4 months
- Weight at study initiation: Male: 2317 ± 60 g; Female: 2421 ± 58 g
- Diet: Four ounces per day
- Water: ad libitum
- Acclimation period: At least two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): 40-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Trunk
- % coverage: Approximately 10%
- Type of wrap if used: Test substance impregnated gauze patch held in place by an elastic rabbit jacket
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was wiped thoroughly with water and dried with a soft disposable towel
- Time after start of exposure: 24 hours
TEST MATERIAL
- For solids, paste formed: Yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Careful in-life observations were made and recorded frequently the day of dosing and at least once each work day throughout the two-week observation period. Routine monitoring on weekends was limited to animal husbandry procedures required to ensure the availability of feed and water. The rabbits were weighed pre-study, the day of treatment and on test days 3, 8 and 15.
- Necropsy of survivors performed: Yes - Statistics:
- Means and standard deviations were calculated for body weights. The data were evaluated for statistical outliers by a sequential test, however, outliers were not routinely excluded from statistical analysis.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: limit dose
- Mortality:
- All rabbits survived
- Clinical signs:
- other: No in-life observations or clinical signs indicative of systemic toxicity were noted
- Gross pathology:
- There were no treatment-related observations made at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal LD50 (rabbits) > 2000 mg/kg (limit dose)
- Executive summary:
The test substance was evaluated for dermal toxicity following OECD guideline 402 and EPA guideline 81-2. Five New Zealand White rabbits per sex received a single, 24-hour, dermal exposure of 2000 mg/kg of test substance. Parameters evaluated included body weights, in-life observations and gross pathologic evaluation.
All rabbits survived the 2000 mg/kg limit test established by the guidelines, therefore, no other dose levels were tested. All rabbits gained or maintained body weight during the two-week observation period.
No in-life observations or clinical signs indicative of systemic toxicity were noted. In addition, no treatment-related observations were made at necropsy.
Under the conditions of this study, the acute dermal LD50 of the test substance was greater than the 2000 mg/kg limit dose, for male and female New Zealand White rabbits.
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