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Registration Dossier
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EC number: 271-264-4 | CAS number: 68527-23-1 A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C9 and boiling in the range of approximately 110°C to 165°C (230°F to 329°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- other: GLP compliant, guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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:
- Naphtha (petroleum), steam-cracked middle arom.
- Test material form:
- liquid
- 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
- Test material data responsibility of study sponsor
Constituent 1
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
- Sex: 5 males and 5 females
- Age at study initiation: Young adults (less than 12 weeks of age)
- Weight at study initiation: 190-350 g at pre-fast. Weights were within 20% of the group mean
- Housing: Individually in stainless steel, wire mesh bottom cages
- Diet: Agway Rodent Feed ad libitum, except overnight prior to dosing
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 64-79°F
- Humidity: 40-70%
- Air changes: At least 10/hr
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From: 23 February 1990 To: 26 February 1990
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Undiluted test article was administered by oral gavage.
- Individual dosing volumes were adjusted based on the density of the test article and the animal's fasted bodyweight. - Doses:
- 5000 mg/kg to each animal
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 4 days
- Frequency of observations and weighing: Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the next 4 days - a total of 5 days of observation.
- Necropsy of survivors performed: yes. Animals dying on test also underwent a post mortem examination.
- Other examinations performed: Animal body weights were recorded on arrival, the day before dosing (pre-fast), the day of dosing (fasted) and at animal death.
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 at 5000 mg/kg
- 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 GHS/CLP.
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