Registration Dossier
Registration Dossier
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EC number: 268-899-4 | CAS number: 68153-95-7 This substance is identified by SDA Substance Name: C12-C18 dialkyl amine and SDA Reporting Number: 16-042-00.
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 and guideline study.
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:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Amines, di-C12-18-alkyl
- EC Number:
- 268-899-4
- EC Name:
- Amines, di-C12-18-alkyl
- Cas Number:
- 68153-95-7
- Molecular formula:
- R2-NH whereas R = mainly C12-18 (even numbered) alkyl molecular weight range is based on R =12 (lower limit value) and R = 18 (higher limit value)
- IUPAC Name:
- N-C12-18-(even numbered)-alkyl-1-C12-18-(even numbered)-amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund,
- Weight at study initiation: ± 185 gram
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Clinical signs , body weight and macroscopy was monitored according to the OECD guideline.
- Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No.
- Clinical signs:
- other: piloerection, curved position, non-coordinated behaviour and non-regular breathing.
- Gross pathology:
- No findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (rat) of the test substance is >2000 mg/kg BW.
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