Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 275-069-5 | CAS number: 70969-58-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 7-29, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted to recognised international test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- Diisobutyl hexahydrophthalate
- EC Number:
- 275-069-5
- EC Name:
- Diisobutyl hexahydrophthalate
- Cas Number:
- 70969-58-3
- Molecular formula:
- C16H28O4
- IUPAC Name:
- bis(2-methylpropyl) cyclohexane-1,2-dicarboxylate
- Details on test material:
- - Name of test material : DIBE (diisobutylhexahydrophthalate)
- Physical state: Liquid
- Lot/batch No.: T60211/349
- Expiration date of the lot/batch: 2012-12-15
- Storage condition of test material: room temperature, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Italia S.p.A.
- Age at study initiation:7 - 8 weeks old
- Weight at study initiation:180- 231 g
- Housing: Group hosed in polysulphone solid bottom cages
- N° of animal/cage: Up to 5/cage during acclimatisation; 3/cage during study period
- Diet: 4 RF 18 (Mucedola S.r,l)
- 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: 2012-06-07 To: 2012-06-29
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- 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 non-soluble/miscible in aqueous vehicles
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 toxcity sed 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:
- other: Salivation in 1 animal following dosing, recoveryt within 4 hours of dosing.
- Gross pathology:
- No abnormal findings
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
