Registration Dossier
Registration Dossier
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EC number: 255-730-4 | CAS number: 42233-75-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Jul - 09 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- (2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Didocosyl sebacate
- EC Number:
- 255-730-4
- EC Name:
- Didocosyl sebacate
- Cas Number:
- 42233-75-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Decanedioic acid, diesters with Fatty alcohols C20-22 (even numbered)
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white solid
- Storage condition of test material: room temperature in the dark
- Expiration date of the lot/batch: 30 Jun 2013
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: (RccHan:WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK, Ltd., Oxon, UK
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 163 – 177 g
- Fasting period before study: overnight before dosing
- Housing: Animals were caged in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet (Harlan Laboratories UK, Ltd., Oxon, UK), ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: Arachis oil was used because the test item did not dissolve/suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not specified - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Frequency of weighing: prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: yes
- Other examinations performed: External appearance, body orifices, body cavities (thoracic and abdominal) and their contents were examined macroscopically
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: no mortalities or clinical signs of toxicity observed
- Mortality:
- No mortalities were observed during the study.
- Clinical signs:
- No clinical sings were observed during the study.
- Body weight:
- All animals showed expected gains in bodyweight during the study period.
- Gross pathology:
- No abnormalities were noted 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
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