Registration Dossier
Registration Dossier
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EC number: 500-457-0 | CAS number: 160901-19-9 1 - 2.5 moles ethoxylated
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- clinical signs of toxicity, body weight and gross necropsy findings were not included in the study report
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Alcohols, C12-13, branched and linear, ethoxylated
- EC Number:
- 500-457-0
- EC Name:
- Alcohols, C12-13, branched and linear, ethoxylated
- Cas Number:
- 160901-19-9
- Molecular formula:
- not applicable; UVCB
- IUPAC Name:
- Alcohols, C12-13, branched and linear, ethoxylated
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nossan - Correzzana, Milano, Italy
- Weight at study initiation: 200 g
- Fasting period before study:
- Housing: In groups of 5/cage in polycarbonate cages type Tecniplast (Gazzada, VA, Italy) with sawdust beddin.
- Diet: Pelleted complete diet
- Water: Tap water from the local network, filtered with Seitz filter, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 55 ± 15
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 960, 800, 665 and 555 mg/mL
- Amount of vehicle: 20 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
- Doses:
- 11100, 13300, 16000 and 19200 mg/kg bw
- 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: The animals were observed for clinical signs and mortality at frequent intervals during the day of dose administration and once daily thereafter. Cageside observation included changes in the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomous and central nervous system, and somatomotor activity and behaviour pattern.
- Frequency of weighing: Rats surviving the observation period were weighed and compared to control animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The LD 50 value and attendant variation was determined from the results by the method given by Thompson-Weil.
Thompson and Weil(1952). Tables for Convenient Calculation of Median Effective Dose(LD50 on ED50) and Instructions in their use. Biometrics, 8, 51.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 14 865 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 13 690 - 15 540
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 13 627 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 12 540 - 14 790
- Mortality:
- 11100 mg/kg bw: 0/5 males and 1/5 females died (24 h post dosing)
13300 mg/kg bw: 2/5 males (24 and 48 h post dosing) and 2/5 females died (24 and 48 h post dosing)
16000 mg/kg bw: 3/5 males (1, 24 and 48 h post dosing) and 4/5 females died (1, 24 and 2x 48 h post dosing)
19200 mg/kg bw: 5/5 males (2 x 24 and 3 x 48 h post dosing) and 5/5 females died (1, 3 x 24 and 48 h post dosing) - Clinical signs:
- other: Not reported
- Gross pathology:
- Not reported
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Based on a study according to OECD guideline 401, the LD50 was 14865 mg/kg bw in male and 13627 mg/kg bw in female rats.
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