Registration Dossier
Registration Dossier
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EC number: 608-307-7 | CAS number: 2901-13-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of study: August 28 - End of study: September 11, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Remarks:
- Principles of Good Laboratory Practice, annex of paragraph 19a, section 1 of the chemical law of July 25, 1994
- Test type:
- standard acute method
Test material
- Reference substance name:
- α,α-Dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 608-307-7
- Cas Number:
- 2901-13-5
- Molecular formula:
- C12 H16 O2
- IUPAC Name:
- α,α-Dimethyl-ethyl ester benzeneacetic acid
- Test material form:
- solid - liquid: suspension
- Details on test material:
- Name: Dimethylphenylessigsäureethylester
Synonyms: EDMPA
Chemical name: Benzeneacetic acid, α,α-dimethyl-, ethyl ester
Certificate of analysis: March 18, 1997
Purity: 99.8%
Appearance: clear, colorless liquid
Solubility: 0.3 g/L in water, miscible with alcohol, acetone and toluene
Batch number: B 0006
Date of production: March 12, 1997
Date of expiry: March 2000
Storage conditions: darkness at approximately 5°C in a refrigerator
Stability and homogeneity in the vehicle: is guaranteed for 4 hours
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HMR, Kastengrund, SPF breeding colony
- Age at study initiation: approx. 7 weeks for males, approx. 8 weeks for females
- Weight at study initiation: 175 g ± 2g for males, 173 g ± 5g for females
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff® R/M-H (V 1534)
- Water (e.g. ad libitum): tap water in plastic bottles
- Acclimation period: at least one day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil (Oleum sesami DAB 10)
- Details on oral exposure:
- Concentration in vehicle: 20 % solution in sesame oil
Maximum dose volume applied: 10 ml/kg body weight - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sexe/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice every day
- Necropsy of survivors performed: yes
- Surviving animals: killed by carbon dioxide asphyxiation, dissected and also examined for macroscopically visible changes.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female animal was found dead at day 2 of the study.
- Clinical signs:
- other: Stupor, decreased spontaneous activity, squatting posture, prone position, sunken flanks, bristled coat, irregular respiration, panting, forward crawling, stilted, uncoordinated and ataxie gait, straddled hind limbs, reduced or no placing reaction, narro
- Gross pathology:
- Necropsy of the decedent female animal revealed the following findings:
- lobular demarcation of the liver
- small intestine full of yellowish mucus
- caecum full of hardened feed-mash
- lungs discolored red
The animals killed at the end of the observation period showed no macroscopically visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in this study, the LD50 of the substance for the male and female Wistar rat is greater than 2000 mg/kg body weight.
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