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EC number: 293-170-2 | CAS number: 91052-13-0
Toxicological information
Acute Toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Dec 2009 - 05 Jan 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No. 8147, November 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
- EC Number:
- 293-170-2
- EC Name:
- Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
- Cas Number:
- 91052-13-0
- Molecular formula:
- not applicable for UVCB substances
- IUPAC Name:
- Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: light yellow transparent oily liquid
- Analytical purity: 100%
- Lot/batch No.: H113021
- Expiration date of the lot/batch: 5 November 2010 (allocated by NOTOX, 1 year after receipt of the test substance)
- Storage condition of test material: RT in the dark, stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: young adult animals (approx. 9-10 weeks old)
- Weight at study initiation: 160-190 g, body weight variation did not exceed ± 20% of the sex mean
- Fasting period before study: animals were deprived of food overnight prior to dosing and until 3-4 h after administration of the test substance, water was available
- Housing: group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, UK).
- Diet: pelleted rodent diet (SM R/M-Z from SSNlFF® Spezialdiaten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 (actual range: 18.4- 21.8)
- Humidity (%): 40-70 (actual range: 31 - 88)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the vehicle was selected based on trial formulations performed at the testing labotatory and on test substance data supplied by the sponsor.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to OECD guideline 423 - 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 observations and weighing: mortality: twice daily; clinical observations: daily; bodyweight: Day 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: According the OECD test guideline 423, Annex 2b, the LD50 was considered to exceed 5000 mg/kg body weight.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Hunched posture and/or piloerection was observed among all females on Day 1.
- Gross pathology:
- Necropsy revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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