Registration Dossier
Registration Dossier
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EC number: 500-451-8 | CAS number: 160901-14-4
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: Recent study to OECD protocol with Good Laboratory Practice Audit
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
Test material
- Reference substance name:
- Rosin, maleated
- EC Number:
- 232-480-4
- EC Name:
- Rosin, maleated
- Cas Number:
- 8050-28-0
- Molecular formula:
- Not applicable as the substance is a UVCB
- IUPAC Name:
- Rosin, maleated
- Details on test material:
- Amber crystalline solid, Batch no PC-00-92
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
- Preliminary study:
- No deaths, no clinical signs, no abnormal findings at necroscopy
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No abnormal findings
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was determined to be > 2000 mg/kg in female rats.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with EEC Directives 67/548, 2001/59 and 99/45, the test item of Rosin, maleated cannot be classified because it cannot be determined whether the LC50 falls in Category IV (< 2000 mg/kg) or outside of the category.
In accordance with the Globally Harmonised System (Regulation (EC) No. 1272/2008) the test item cannot be classified because it cannot be determined whether the LC50 falls in Category V (< 5000 mg/kg) or outside of the category. - Executive summary:
In an acute oral toxicity study, 5 female Sprague-Dawley rats were given a single oral dose of rosin, maleated (CAS 8050 -28 -0) in maize oil at a dose of 2000 mg/kg.
There were no treatment related clinical signs, necropsy findings or changes in body weight. The oral LD50 was determined to be > 2000 mg/kg in female rats.
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