Registration Dossier
Registration Dossier
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EC number: 272-180-0 | CAS number: 68783-04-0 A complex combination of hydrocarbons obtained as the extract from the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted to proposed GLP guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- 64742-04-7
- Cas Number:
- 64742-04-7
- IUPAC Name:
- 64742-04-7
- Reference substance name:
- Untreated distillate aromatic extract
- IUPAC Name:
- Untreated distillate aromatic extract
- Test material form:
- liquid: viscous
- Details on test material:
- Untreated distillate aromatic extract (CAS 64742-04-7)
Sample F-47-01; Tufflo 491
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 10
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
All rats survived and gained weight over the 14 day
observation period. There were no clinical signs of toxicity.
No treatment-related lesions were observed at gross
necropsy.
The LD50 of the test material was > 5000 mg/kg.
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 in the rat was > 5000 mg/kg bw
- Executive summary:
Justification for read across
Treated distillate aromatic extracts (TDAEs) are a further processing of untreated distillate aromatic extracts (UDAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from UDAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). Where treatment was sufficient to reduce the 3-7 ring PACs (<3 wt% DMSO extractables as measured by IP-346), the material is most similar to a lubricating base oil and it is this data that should be used for read across.
Male and female rats were administered a single oral dose of undiluted distillate aromatic extract at a dose of 5000 mg/kg bw. There were no deaths during the 14 day observation period.
No treatment-related lesions were observed at gross necropsy.
The LD50 of the test material was > 5000 mg/kg.
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