Registration Dossier
Registration Dossier
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EC number: 297-462-0 | CAS number: 93572-32-8
Toxicological information
Acute Toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 11 Jan - 12 Mar 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Glycerides, C16-18 mono- and di-
- EC Number:
- 286-490-9
- EC Name:
- Glycerides, C16-18 mono- and di-
- Cas Number:
- 85251-77-0
- IUPAC Name:
- 85251-77-0
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rat Ico: OFA.SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA-CREDO, L'Arbreles, France
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 163-172 g (males) and 138-149 g (females)
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: animals were housed in groups of 5 per sex in polycarbonate cages type MI (365 x 225 x 180 mm) with dust-free sawdust bedding from spruce tree wood.
- Diet: pelleted complete diet, diet reference A04 C10 (Usine d'Alimentation Rationnelle, Epinay/Orge, France), ad libitum
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (w/w)
- Lot/batch no.: A28557/1
- Purity: pure
Test substance preparation was administered within 4 hours of preparation.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 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: animals were observed for clinical signs 15 min, 1 h, 2 h and 4 h after administration of the test subsatnce and daily during the 14-day observation period. Individual body weights were determined on Day -1, immediately before administration on Day 0, and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
- Preliminary study:
- In a preliminary study, 2.5, 5 and 10% of the test substance in vehicle (corresponding to 500, 1000 and 2000 mg/kg bw) were administered to 2 males and 2 females per test group. No mortality was observed at any of the concentrations tested. Thus, a dose of 2000 mg/kg bw (10% test concentration) was chosen for the main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality way observed during the study period.
- Clinical signs:
- other: There were no abnormal clinical signs in any of the treated animals during the observation period.
- Gross pathology:
- There were no macroscopic findings at necropsy.
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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