Registration Dossier
Registration Dossier
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EC number: 293-411-1 | CAS number: 91079-24-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted to recognised international test guidelines. For read across justification see Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Oils, fish, sulfated, sodium salts
- EC Number:
- 262-992-3
- EC Name:
- Oils, fish, sulfated, sodium salts
- Cas Number:
- 61788-64-5
- Molecular formula:
- not available (substance is a UVCB)
- IUPAC Name:
- not applicable
- Details on test material:
- - Name of test material : P2
- Physical state: Liquid
- Lot/batch No.: 0003
- Expiration date of the lot/batch: 2012-07-01
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 7 - 8 weeks old
- Weight at study initiation: 156 - 188 g
- Housing: Group hosed in polycarbonate cages 59x38.5x20 cm
- N° of animal/cage: Up to 5/cage during acclimatisation; 3/cage during study period
- Diet: 4 RF 18 (Mucedola Srl)
- Diet supply: ad libitum except for an overnight fast prior to dosing and 4 hours following dosing.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°c +/- 2°c
- Humidity (%): 55% +/- 15%
- Air changes: 15 to 25 air changes per hour
- Photoperiod: Artificial (fluorescent tubes) , daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 2011-10-26 To: 2011-11-18
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% aqueous
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bodyweight
- Justification for choice of vehicle: Substance soluble/miscible in selected vehicle
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION (if unusual): Admixture w/v
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Expected lack of toxicity based on information from structurally analogous substances - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs 0.5, 2 and 4 hours after treatment and daily observations thereafter; bodyweights were determined before treatment and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- no statistics performed
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- 0/6 animals
- Clinical signs:
- None observed
- Body weight:
- Changes in body weight were not remarkable
- Gross pathology:
- Uterine cyst noted in 1 animal
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute oral toxicity of the substance has been investigated according to OECD/EU test guidelines. The LD50 was determined to be in excess of 2000 mg/kg body weight.
- Executive summary:
Acute oral toxicity of the substance has been investigated according to OECD/EU test guidelines. The LD50 was determined to be in excess of 2000 mg/kg body weight.
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