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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
