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EC number: 443-870-0 | CAS number: 163520-33-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Feb - 05 May 1994
- 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 401 (Acute Oral Toxicity)
- Version / remarks:
- Adopted in 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- Adopted in 1988
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Agricultural chemicals, Laws and Regulations Japan, MAFF (p. 19 - 20)
- Version / remarks:
- Adopted in 1985
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 443-870-0
- EC Name:
- -
- Cas Number:
- 163520-33-0
- Molecular formula:
- C18H17NO3
- IUPAC Name:
- ethyl 5,5-diphenyl-4,5-dihydro-1,2-oxazole-3-carboxylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- WISKf(SPF71)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF breeding colony, Hoechst AG, Kastengrund, Germany
- Age at study initiation: males: approx. 6 weeks, females: approx. 7 weeks
- Body weight at study initiation: males: 183 g (mean), 169 - 199 g (range); females: 173 g (mean), 162 - 180 g (range)
- Fasting period before study: 16 h before treatment to 3 - 4 h after treatment
- Housing: Makrolon cages (Type 4) on soft wood granulate in groups of 5 animals
- Diet: Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water in drinking water quality, ad libitum
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 6.25, 12.00, 20.00, 25.00, and 50.00% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test substance was suspended in the above stated concentrations in sesame oil with mortar and pestle and distributed homogeneously by means of a magnetic stirrer. - Doses:
- 625, 1250, 2000, 2500, and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males (625 mg/kg bw dose group)
5 males and 5 females (1250 - 5000 mg/kg bw dose groups) - Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 15 days (16 days for 1250 mg/kg bw dose group for technical reasons)
- Frequency of observations and weighing: Animals were observed for mortality/moribundity and clinical signs 10, 30, 60 min and 2, 4, and 6 h after dosing, twice daily from Day 2 to 6 and daily thereafter until the end of the observation period. Individual body weights were determined weekly.
- Necropsy of survivors performed: yes - Statistics:
- The LD50, the 95% limits of confidence and the equation of the probit lines were established on the basis of the mortality rates by probit analysis. The LD50 values were calculated for males and females separately. To get one probit line, a goodness-of- fit-test (Pearson) was performed with a 5% level of significance. Then the limits of confidence were calculated according to the method of FIELLER.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 740 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 251 - <= 2 245
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 611 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 904 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 625 mg/kg bw: 0/5 males died
1250 mg/kg bw: 3/5 males (48 - 72 h post-dose) and 1/5 females (6 days post-dose) died
2000 mg/kg bw: 2/5 males (48 h post-dose) and 2/5 females (48 h and 13 days post-dose) died
2500 mg/kg bw: 4/5 males (48 - 72 h post-dose) and 4/5 females (48 - 96 h post-dose) died
5000 mg/kg bw: 5/5 males (48 h post-dose) and 5/5 females (48 - 96 h post-dose) died - Clinical signs:
- other: Clinical signs of intoxication did not significantly differ in type, incidence, and severity between male and female animals. Incidence and severity of clinical signs were dose-dependently increased with ascending dose. They began to emerge 1 h after admi
- Gross pathology:
- 625 mg/kg bw:
Necropsy revealed no test substance-related findings.
1250 mg/kg bw:
- animals found dead: general autolysis, small intestine full of a reddish-black mass, positive in the faecal occult blood test
- animals sacrificed at termination: Necropsy revealed no test substance-related findings.
2000 mg/kg bw:
- animals found dead: general autolysis, liver with light discolouration, small intestine discoloured by test substance and full of test substance
- animals sacrificed at termination: Necropsy revealed no test substance-related findings.
2500 mg/kg bw:
- animals found dead: general autolysis, liver with light discolouration and lobular demarcation, lungs discoloured red, small intestine full of test substance, and reddish black mass
- animals sacrificed at termination: Necropsy revealed no test substance-related findings.
5000 mg/kg bw:
- animals found dead: general autolysis, liver with light discolouration and lobular demarcation, lungs discoloured orange, stomach full of test substance, small intestine full of test substance, and reddish black mass
Any other information on results incl. tables
Table 1. Table for acute oral toxicity.
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
625 |
0/5/5 |
1 h – Day 2 |
--- |
0 |
1250 |
3/5/5 |
2 h – Day 3 |
Day 2 + Day 3 |
60 |
2000 |
2/5/5 |
2 h – Day 2 |
Day 2 |
40 |
2500 |
4/5/5 |
2 h – Day 5 |
Day 2 + Day 3 |
80 |
5000 |
5/5/5 |
1 h - death |
Day 2 |
100 |
Females |
||||
650 |
0/0/0 |
--- |
--- |
--- |
1250 |
1/4/5 |
4 h - Day 6 |
Day 6 |
20 |
2000 |
2/5/5 |
2 h - Day 14 |
Day 2 + Day 13 |
40 |
2500 |
4/5/5 |
2 h - Day 4 |
Day 2 + Day 4 |
80 |
5000 |
5/5/5 |
2 h - death |
Day 2 - Day 4 |
100 |
LD50 = 1740 mg/kg bw |
* number of dead animals/number of animals with clinical signs/number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- other: Acute Oral Cat. 4 (H302) according to Regulation (EC) No 1272/2008
- Conclusions:
- In the present acute oral toxicity study in rats a LD50 value of 1740 mg/kg bw for both sexes was determined.
The LD50 value was 1611 mg/kg bw for males and 1904 mg/kg bw for females, respectively.
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