Registration Dossier
Registration Dossier
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EC number: 270-729-9 | CAS number: 68477-40-7 A complex combination of hydrocarbons obtained by distilling cracked stripped steam-cracked distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers in the range of C10 through C12.
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- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction
- EC Number:
- 270-729-9
- EC Name:
- Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction
- Cas Number:
- 68477-40-7
- IUPAC Name:
- Cracked Distillate
- Reference substance name:
- Cracked distillate
- IUPAC Name:
- Cracked distillate
- Details on test material:
- - Name of test material (as cited in study report): "Cracked distillate"
- Physical state: brown/green liquid
- Components: (by weight): - naphthalene (15-35), methylnaphthalene (5-10), 13-methylnaphthalene (5-10), di, tri, tetra-methylnaphthalene (< 5), paraffins (1-20), alkylbenzenes (< 5), indene, alkylindenes and alkylindanes (20-30), compounds with higher boiling points (< 5)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: males 131-153g; females 112-129 g
- Fasting period before study: overnight
- Housing: In groups of 5, sexes separately in stainless steel cages with wire screen bottoms and fronts.
- Diet: Cereal based, open formula basal diet ad libitum (except for overnight fast prior to dosing)
- Water: Tap water ad libitum
- Acclimatisation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Photoperiod: 12hrs dark / 12hrs light)
IN-LIFE DATES: From: 5 July 1989 To: 19 July 1989
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bodyweight
- Doses:
- 2000 mg/kg bodyweight
- 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 frequently during the first 4 hours and once per day thereafter. Bodyweights recorded on days 0, 3, 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality at highest dose tested
- Mortality:
- None
- Clinical signs:
- other: After 1 and 4 hours all showed severe/moderate signs of sluggishness and moderate piloerection. After 24 hours 3 females showed moderate soiled fur. No signs at any other time.
- Gross pathology:
- No abnormalities detected.
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 of "cracked distillate" is in excess of 2000 mg/kg bodyweight.
- Executive summary:
The acute oral toxicity of E000144600 (CAS 68477-40-7) was determined in a group of 5 male and 5 female rats administered a single dose of undiluted test substance at 2000 mg/kg. There was no mortality and all animals had gained weight on day 3. The acute oral LD50 of "cracked distillate" is in excess of 2000 mg/kg bodyweight to male and female rats. No classification is warranted under Dir 67/548/EEC or GHS/CLP.
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