Registration Dossier
Registration Dossier
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EC number: 309-870-9 | CAS number: 101316-66-9 A complex combination of hydrocarbons obtained during the sorptions of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80°C to 135°C (176°F to 275°F).
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Naphtha (petroleum), steam-cracked middle arom.
- EC Number:
- 271-138-9
- EC Name:
- Naphtha (petroleum), steam-cracked middle arom.
- Cas Number:
- 68516-20-1
- IUPAC Name:
- 68516-20-1
- Reference substance name:
- E000144700
- IUPAC Name:
- E000144700
- Details on test material:
- - Name of test material (as cited in study report): E000144700
- Physical state: Clear, pale yellow to yellow liquid, gasoline-like naphtha odour
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Stable
- Storage condition of test material: 50-80°F
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sasco, Inc., Omaha, Nebraska, USA.
- Age at study initiation: Young adults (< 12 weeks)
- Weight at study initiation: 190-350 g (pre-fast)
- Fasting period before study: overnight
- Housing: Individually in stainless steel, wire mesh bottom cages
- Diet: Agway Rodent Feed ad libitum (except during overnight pre-dose fast)
- Water: Fresh potable water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 64-79°F
- Humidity: 40-70%
- Air changes: At least 10/hour
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From: 23 February 1990 To: 9 March 1990
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSE VOLUME: 5 mL/kg. Individual dose volumes were adjusted based on the density (0.9145 g/mL) and the animals bodyweight.
- Doses:
- 5000 mg/kg
- 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 and weighing: Observations hourly for initial 4 hours after dosing, twice daily thereafter. Bodyweights recorded pre-fast, pre-dose, week 1 and at termination.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: 1/10 mortalities and no significant macroscopic findings at only dose tested
- Mortality:
- 0/5 males, 1/5 females (day 3).
- Clinical signs:
- other: All of the animals on study exhibited one or more of following: oral / nasal / ocular discharge, tremors, ataxia, abnormal stools, lethargy, moribund, stained coat, alopecia, hunched posture.
- Gross pathology:
- One animal had alopecia in abdominal area, one had staining in the nasal and perineal regions.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 for E000144700 is greater than 5000 mg/kg.
- Executive summary:
The acute oral toxicity of E000144700 (CAS 68516-20-1) was determined in a group of 5 male and 5 female rats administered a single dose of undiluted test substance at a dose of 5000 mg/kg. One of the animals died and adverse clinical signs including oral / nasal / ocular discharge, tremors, ataxia, abnormal stools, lethargy, moribund, stained coat, alopecia, hunched posture were observed.
The acute oral LD50 is greater than 5000 mg/kg and no classification is warranted under Dir 67/548/EEC or under GHS/CLP.
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