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Diss Factsheets
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EC number: 231-810-4 | CAS number: 7747-35-5
- 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
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Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: (meets generally accepted scientific standards and is described in sufficient detail)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-2 (Repeated Dose Dermal Toxicity -21/28 Days)
- Deviations:
- no
- Remarks:
- Not specified in the report.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole
- EC Number:
- 231-810-4
- EC Name:
- 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole
- Cas Number:
- 7747-35-5
- Molecular formula:
- C7H13NO2
- IUPAC Name:
- 7a-ethyl-tetrahydro-1H-[1,3]oxazolo[3,4-c][1,3]oxazole
- Details on test material:
- TS: 96% pure
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- Dosed daily, 6 hours per day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100, and 300 mg/kg bw /day
Basis:
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Wistar rats (male and female) were obtained from a commercial supplier, and were identified by ear tags. They were quarantined and acclimated to the testing facility for 12 days prior to study assignment. The animals were offered food and water ad libitum, and were individually housed in rooms designed to maintain adequate environmental conditions for the species.
Five days prior to the dose application, the animals were randomly distributed into 4 groups based on body weights. At weekly intervals (for 2 weeks) beginning on the day before the first test material application, the fur was clipped from the upper dorso-lateral area of each animal accounting for approximately 10% of the total body surface. In an attempt to obtain a non-irritating dose, the material was diluted to 2.5%, 5%, 7.5%, and 10%. Three males and females were dosed at each level for 11 days prior to the definitive test. The test material was evenly spread on surgical gauze, which was affixed to aluminum foil with a thin layer of vaseline. The patch was applied to the clipped area of each rat, and was reapplied daily for a 6 hour exposure period.
Cageside observations were performed once daily until sacrifice on day 21. Once weekly, animals were given a detailed physical examination. Body weights were taken on day 0, 7, 14, 20 (prior to fasting), and 21 (fasting). Hematology and clinical chemistry was evaluated using day 21 blood samples collected at necropsy.
A full gross necropsy was conducted, and included external surfaces and openings, and the contents of the cranial, thoracic, and abdominal cavities. Liver, adrenals, kidneys, and testes were removed and weighed.
Means with standard deviation were calculated for all quantitative parameters. One-way ANOVA was used to analyze the results for overall effects of dosage. Significant differences between doses were also assessed by using the F-test where p<0.05. The following variables were selected for futher statistical analyses: body weights, food consumption, organ weights, and organ/body weight ratios of liver, kidney, adrenal, and testes, and all parameters suspected of changes from the hematology and clinical chemistry determinations. A homogeneity of variance test using the Bartlett method was also performed.
Examinations
- Statistics:
- Means with standard deviation were calculated for all quantitative parameters. One-way ANOVA was used to analyze the results for overall effects of dosage. Significant differences between doses were also assessed by using the F-test where p<0.05. The following variables were selected for futher statistical analyses: body weights, food consumption, organ weights, and organ/body weight ratios of liver, kidney, adrenal, and testes, and all parameters suspected of changes from the hematology and clinical chemistry determinations. A homogeneity of variance test using the Bartlett method was also performed.
Results and discussion
Results of examinations
- Details on results:
- There were no treatment-related mortalities, and no evident signs of systemic toxicity noted. The treated surface showed dose- or concentration-related local skin irritation, observed as necrotic erythema and topical eschar and scar formation, seen in all animals of both the medium and high dose groups. Most animals of the low dose group showed erythema on three or more occasions, and eschar formation was seen in only two animals. The reported incidence of erythema and crust formation was 56%, 34%, 16%, and 3% for high, mid, low, and control groups, respectively.
There were no biologically-significant effects on body weights or food consumption in any group, nor any changes in hematology parameters or clinical chemistry parameters.
High-dose females showed a statistically-significant increase in kidney/body weight ratio. Gross pathology revealed no significant findings, other than local eschar formation at the test sites. Histopathological findings included erosion, chronic dermatitis, or local subepidermal infiltrate.
The NOEL by dermal application for 21 days was reported to be 100 mg/kg/day.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL by dermal application for 21 days was reported to be 100 mg/kg/day.
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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