Registration Dossier
Registration Dossier
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EC number: 701-361-3 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 March 1993 to 30 December 1993
- 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:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 19 September 1984
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Acute Toxic Class Method (ATC Method) by E. Schlede, U. Mischke, R. Roll, D. Kayser: A National Validation Study of the Acute-Toxic-Class Method - An Alternative to the LD50 Test. Arch. Toxicol. 66: 455-470 (1992).
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylic acid (<6.5 mol EO and <6.5 mol PO)
- EC Number:
- 701-361-3
- Molecular formula:
- C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x . x C3 H4 O2
- IUPAC Name:
- Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylic acid (<6.5 mol EO and <6.5 mol PO)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: P. 28/93
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, exclusion from light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach
- Age at study initiation: not spezified (young adult animals)
- Weight at study initiation: mean body weigt of three male animals: 183 g; mean body weight of three female animals: 180 g
- Fasting period before study: no feed at least 16 hrs before administration, but water was available ad libitum
- Housing: single housing
- Diet: Kliba diet 343, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10 March 1993 To: 25 March 1993
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 mg/mL
- Amount of vehicle: 5 mL/kg bw
- Justification for choice of vehicle: test substance is insoluble in aqua bidest
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- -Duration of observation period following administration: 14 days
-Frequency of observation and weighing: animals were checked for mortality twice each workday and once on saturday, sunday and on public holidays for general observations and for any dead or moribund animals. Weighing was performed before application (day 0), weekly thereafter and at the end of the study. Recording of toxicological signs and symptons several times on the day of administration, at least once each workday for the individual animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and symptoms, body weight, general observations and mortality, pathology
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No abnormalities were observed.
- Gross pathology:
- Necropsy at the end of the study revealed no abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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