Registration Dossier
Registration Dossier
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EC number: 273-050-6 | CAS number: 68936-98-1 The complex combination of hydrocarbons produced by the distillation of products from cumene manufacturing process. It consists primarily of diisopropylbenzene with various small amounts of C4 substituted benzenes and heavier non-aromatic hydrocarbons.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline 423 (adopted 2001)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Phycher Bio Developpement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Cumene bottoms (benzene, (1-methylethyl)-, distn. residues)
- IUPAC Name:
- Cumene bottoms (benzene, (1-methylethyl)-, distn. residues)
- Details on test material:
- Batch No : 341309
CAS No: 68936-98-1
liquid
Colour: yellow
Storage: +6°C ± 3°C, protected from light
Expiry date: 12 March 2011
Purity: 100% (UVCB)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Source: Elevage JANVIER (France)
acclimatization period: at least five days
body weighed 185- 222 g
8 or 9 weeks old.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 2000 mg/kg bw (2.32 mL/kg bw test item)
- No. of animals per sex per dose:
- 6 females
- Control animals:
- yes
- Details on study design:
- according to Guideline
- Duration of observation period following administration: 14 days
- Frequency of observations (and weighing): once daily (day 0, 2, 7, 14)
- Necropsy of survivors performed: yes
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: Limit test
- Mortality:
- no mortality
- Clinical signs:
- other: During the fIrst day of the test, a decrease in spontaneous activity (3/6) and in Preyer's reflex (1/6), an increased salivation (1/6) and a piloerection (3/6) were noted. All effects reversible within 24 h
- Gross pathology:
- No treatment related changes.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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