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Diss Factsheets
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EC number: 619-636-0 | CAS number: 125971-57-5
- 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
- Study period:
- 1989-11-28 to 1990-12-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study was conducted according to GLP guidelines as described by the FDA (21 CFR Part 58) and standard operating procedures
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 402 not explecitely mentioned but similar
- GLP compliance:
- yes
- Test type:
- other:
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): 89-0292 and PD 132,408
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc. Boyertown, PA
- Weight at study initiation: 1.94-2.48 kg
- Fasting period before study: no
- Housing: stainless stell cage
- Diet: Food and water ad libitum
- Acclimation period: >5 days before study initiation
ENVIRONMENTAL CONDITIONS
All housing and care conformed to the standard established in the "Guide for the care and use of laboratory animal" DEHW Publication No. (NIH) 85-23
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: plastic
REMOVAL OF TEST SUBSTANCE
- Washing (if done): sites were wiped gently with clean gauze
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
VEHICLE
- Amount applied to the control group: 2000 mg/kg - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg (Limit test) for each sex
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: hourly for six hours after the treatment; twice daily thereafter
- Weighing on day: 0, 1, 3, 7, 11, 14
- Necropsy of survivors performed: gross necropsy. The external body surface and orifices, major visceral organs, body cavities and the carcass were examined - Statistics:
- Analysis of variance for the weight differences
Results and discussion
- Preliminary study:
- limit test
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
Anorexia, diarrhea, a gel like substance in the waste tray, nasal discharge and soft stools were noted in both groups during the observation period. The observations were considered incidential and unrelated to dose administration. - Body weight:
- Two test and three control animals lost weight from study initiation to termination. No compound related statistical significance (analysis of variance) was noted when the test group was compared to the control group.
- Gross pathology:
- No treatment related changes in the organs.
- Other findings:
- Erythema and edema were found immediatly after binder removal in both treated and control animals with various severity but subsided within 24h hours
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute dermal LD50 of PD 132,408 is considered to be greater than 2000 mg/kg bodyweight.
- Executive summary:
All animals in both the test and the control groups survived to study termination following dose administration. Two test and three control animals lost weight from study initiation to termination. Under the conditions of this study, the acute dermal LD50 of PD 132,408 is considered to be greater than 2000 mg/kg bodyweight.
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.
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