Registration Dossier
Registration Dossier
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EC number: 271-487-7 | CAS number: 68564-88-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 1973 to December 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- The study was performed before the implementation of the guideline
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 11-(heptylamino)undecanoic acid
- EC Number:
- 271-487-7
- EC Name:
- 11-(heptylamino)undecanoic acid
- Cas Number:
- 68564-88-5
- Molecular formula:
- C18H37NO2
- IUPAC Name:
- 11-(heptylamino)undecanoic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- The Test item was dissolved in suspension in CMC 0,5%.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 5 Animals per cage , diet provided ad libitum with water
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- The test item was adminitered by gavage twice at 3 hours interval at 5 g/kg in total 10g/kg per animals
- Doses:
- 10 g/kg
- No. of animals per sex per dose:
- 8 males and 8 females
- Control animals:
- no
- Details on study design:
- 8 males and 8 females were administered the test item at 3 hours interval a dose level of 5 g/kg in 0,5 carboxymethylcellulose for each administration, in total 10g/kg was administered for each animal.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 10 other: g/kg
- Based on:
- test mat.
- Mortality:
- no mortality was observed.
- Clinical signs:
- no clinical signs was observed.
- Body weight:
- animals were about 180g to 200 g of body weight
- Gross pathology:
- not examined
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The DL0 was higher than 10g/kg, acute toxicity of n-Hau is low.
- Executive summary:
The test item was administered orally twice in 8 males and 8 females at 3 hours interval at 10 g/kg in total. No mortality or clinical signs was recorded, therfore the LD0 was higher than 10g/kg
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