Registration Dossier
Registration Dossier
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EC number: 931-105-8 | CAS number: -
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
Test material
- Reference substance name:
- reaction product of L-isoleucine, C12-C22-alkyl esters, and an alkylsulfonic acid.
- IUPAC Name:
- reaction product of L-isoleucine, C12-C22-alkyl esters, and an alkylsulfonic acid.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- other: syringe and dosing needle
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females at 2000mg/kg
- Control animals:
- no
- Details on study design:
- Initially, a single female Sprague Dawley rat was dose orally with Octododecanol Isoleucinate Mesylate (D-585-099) at a dose level of 2000 mg/kg. Since the animal survived, four additional females were dose at 2000 mg/kg. The rats were observed at 15 minutes, 1,2 and 4 hours postdose and once daily for 14days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology. The potential for toxicity was based on the mortality response noted.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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