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EC number: 431-090-3 | CAS number: 190085-41-7
- 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
- Study period:
- 20 February 1998 to 19 August 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- dated February 24, 1987
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 431-090-3
- EC Name:
- -
- Cas Number:
- 190085-41-7
- Molecular formula:
- C19 H30 O3
- IUPAC Name:
- 2-butyloctyl 2-hydroxybenzoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Cr1:CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston, New York 12484 (USA)
- Age at study initiation: young adults at least 9-12 weeks old
- Weight at study initiation: males, 275-315 g; females, 214-221 g
- Fasting period before study: none
- Housing: group housed (6/cage) during acclimation; individually in suspended stainless steel cages with wire mesh bottoms during the study
- Diet (ad libitum): Certified Rodent Diet No. 5002 (PMI Nutrition International, St. Louis, Missouri, USA)
- Water (ad libitum): municipal water supply (Elizabethtown Water Company, Westfield, New Jersey, USA).
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 28-62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (automated timer)
IN-LIFE DATES: From: 26 February 1998 To: 12 March 1998
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Preparation of animals:
Approximately 24 hours before dosing, the hair of each rat was closely clipped from the trunk (dorsal surface area and sides from scapular to pelvic areas) with an electric clipper exposing at least 10% of the body surface area (approximately 6 cm x 6 cm). The skin was not abraded.
Administration:
Applied to the clipped skin of the dorsal trunk surface. Doses were calculated using pretest (Day 1) body weights. The material was applied directly onto the exposed skin of the animal and spread evenly over the entire area. A layer of 8-ply gauze was then placed over the application site. The gauze was then covered with impervious plastic and secured with an Elastoplast bandage. Following approximately 24 hours, the wrappings were removed and the site wiped free of excess test material with gauze moistened with 0.9% saline. - Duration of exposure:
- approximately 24 hours
- Doses:
- A single dose level, 2000 mg/kg bwt
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of study:
A single dose was administered to each animal, followed by 14 days of observations.
Observations:
Observations for mortality were made twice daily. Each animal was removed from its cage and observations of general condition, skin and fur, eyes, nose, oral cavity, abdomen and external genitalia as well as evaluations of respiration and palpation for tissue masses were made. All abnormalities, including severe dermal effects, were recorded.
Evaluation of dermal irritation:
Dermal irritation was scored (Table 1) approximately 60 minutes, 24, 48, and 72 hours after bandage removal and daily thereafter. At each interval, treatment sites were evaluated for erythema and edema and other evidence of dermal irritation. Special notation was made of tissue damage, eschar, other evidence of irreversible alteration of tissue structure, and any other dermal abnormalities.
Body weights:
These were obtained on Day 0 (at time of clipping), on Day 1 (just before dosing) and on Days 8 and 15.
Food consumption:
Each animal’s quantity of feed was visually inspected, and any qualitative decreases in food consumption, relative to other animals on test, were recorded.
Postmortem:
At study termination (Day 15), all animals were euthanatized by exsanguination following carbon dioxide anesthesia. Necropsy included macroscopic examinations of all external surfaces and orifices, the organs and tissues of the cranial, thoracic, abdominal and pelvic cavities and neck and remainder of the carcass. All abnormalities were recorded and any tissues with lesions were saved. - Statistics:
- Based on the study results, calculation of an LD50 value was not applicable.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There was no mortality reported.
- Clinical signs:
- other: Six of the ten animals exhibited slight red stains on the snout on the day of dosing. All animals were free of clinical signs by Day 2. The test material did not cause dermal irritation with no irritation scores other than 0 reported during the study.
- Gross pathology:
- A single animal at necropsy exhibited slightly firm, slightly white discolored lungs. All other animals were free of macroscopic abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the dermal LD50 of Hallbrite BHB in rats is greater than 2000 mg/kg bwt.
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