Registration Dossier
Registration Dossier
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EC number: 629-661-9 | CAS number: 83834-59-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Similar to current guideline studies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Principles of method if other than guideline:
- Method: other: BASF test
- GLP compliance:
- no
- Test type:
- other: BASF-Test
- Limit test:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl 4-methoxycinnamate
- EC Number:
- 226-775-7
- EC Name:
- 2-ethylhexyl 4-methoxycinnamate
- Cas Number:
- 83834-59-7
- Molecular formula:
- C18H26O3
- IUPAC Name:
- 2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester, (2E)-
- Details on test material:
- - Name of test material (as cited in study report): Lusantan MCE
- Lot/batch No.: 2/4/83
- Physical state: liquid
- Analytical purity: approx 100%
- Expiration date of the lot/batch: Stability > 2 years
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K Tomae GmbH, Biberach, Germany
- Mean weight at study initiation: 170 g male / 190 g female
- Fasting period before study: 16 h (water ad libitum)
- Housing: Stainless steel wire mesh cages Type DK-III (Becker & Co., Castrop-Rauxel, Germany); 5 animals per cage
- Water: ad libitum
- Acclimation period: >1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % preparation aqueous of carboxymethylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 % (w/v)
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: min. 1/day (symptoms); min 1/day (moribund/dead animals); weighing on d3, d7, d13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No deaths occurred (male/fermale)
- Clinical signs:
- other: no abnormalities (male/fermale)
- Gross pathology:
- no abnormalities (male/fermale)
Applicant's summary and conclusion
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