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Registration Dossier
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EC number: 265-111-0 | CAS number: 64742-11-6 A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 401.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 64742-05-8
- IUPAC Name:
- 64742-05-8
- Reference substance name:
- Light paraffinic distillate solvent extract
- IUPAC Name:
- Light paraffinic distillate solvent extract
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): API 83-16
- Physical state: Liquid, brown
- Viscosity, SSU: 67.2 at 100°F
- API Gravity: 16.7
- Flash Point: (°F) 335
- Pour Point (°F): 20
- Aniline Point (°F): 95.5
- Sulfur, Wt %: 2.64
- Composition of test material ASTM D-2007, Wt. %:
Saturates: 29.2
Aromatics 68.6
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: Charles River Laboratories, Inc., Stone Ridge, NY
- Age at study initiation: 7 weeks old
- Weight at study initiation: 316 to 346 g (males), 234 to249 g (females)
- Fasting period before study: Overnight before dosing
- Housing: Group cages
- Diet (e.g. ad libitum): Purina certified rodent chow 5002, ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 52 to 66
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 03-12-1984 To: 17-12-1984
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5.43 mL/kg body weight based upon average bulk density of 0.92 g/mL = 5000 mg/kg body weight
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for clinical signs and mortality at hourly intervals during the first 6 hours after test material administration and twice daily thereafter for 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, mortality - Statistics:
- No data reported.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/10
- Clinical signs:
- other: Clinical signs of toxicity observed included hypoactivity, ataxia, red stained face, yellow-stained anal area, diarrhoea, and oily haircoat. All animals had returned to normal within 8 days of test material administration.
- Gross pathology:
- No visible lesions
- Other findings:
- Initial: 314g (male), 231g (female)
Day 7: 343g (male), 246g (female)
Terminal: 386g (male), 267g (female)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information LD50 >5000 mg/kg bw Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the oral LD50 for male and female rats administered light paraffinic distillate solvent extract was greater than 5000 mg/kg body weight. According to EU criteria, the test material is not classified.
- Executive summary:
In an acute oral toxicity study, groups of fasted, 7 week old Sprague-Dawley rats (5/sex) were given a single oral dose of undiluted light paraffinic distillate solvent at a dose of 5000 mg/kg body weight. Animals were observed for 14 days.
Clinical signs observed included: hypoactivity, ataxia, red stained face, yellow-stained anal area, diarrhoea, and oily haircoat. All animals had returned to normal within 8 days of test material administration. The oral LD50 was determined to be greater than 5000 mg/kg body weight in males and females.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 401.
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