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Diss Factsheets
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EC number: 436-230-7 | CAS number: 359406-89-6
- 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
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Acute Toxicity: dermal
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across fromsupporting substance. Guideline study to GLP.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- other: Liquid.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zeneca Pharmaceuticals, Alderley Park, Macclesfield, Cheshire UK
- Age at study initiation: young adults
- Weight at study initiation: 273-299 g(m) 206-226 (f)
- Fasting period before study: not applicable
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: from 14 November 1995 to 28 November 1995
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 7cm x 7cm
- % coverage: not stated
- Type of wrap if used: gauze patch covered by plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, washed with water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 14-16 mg/cm2 (males); 11-12 mg/cm2 (females)
- Concentration (if solution): 300 mg/ml
- Constant volume or concentration used: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): water, to give dilution to 300 mg/ml test substance - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once between 1 and 4 hours post-application, then daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs including local effects, body weight
Results and discussion
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:
- other: Signs of toxicity related to dose levels: No deaths occurred and no signs of systemic toxicity were observed.
- Gross pathology:
- Effects on organs:
No treatment-related macroscopic findings were observed. - Other findings:
- Signs of toxicity (local):
Slight to moderate irritation was observed in all the animals. Signs of necrosis were observed in two males and in one female. There was clear evidence of recovery and repair in these animals at the end of the observation period.
The test sample stained the application sites yellow but this did not prevent the accurate clinical assessment of erythema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 is greater than 2000 mg/kg. ITC 826 Concentrate is not classified for acute dermal toxicity.
- Executive summary:
A sample of ITC 826 Concentrate was assessed for its acute dermal toxicity. A group of five male and five female rats received a single dermal application of 2000 mg/kg (corrected for water content) of the test sample. The animals were assessed daily for any signs of systemic toxicity and dermal irritation and their bodyweights were recorded at intervals throughout the study. At the end of the study, the animals were killed and subjected to a macroscopic post mortem examination.
None of the animals died and there were no significant signs of systemic toxicity. Moderate irritation was observed in both males and females. The acute dermal median lethal dose of the test sample is in excess of 2000 mg/kg for male and female rats.
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.
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