Registration Dossier
Registration Dossier
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EC number: 291-443-0 | CAS number: 90411-66-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLP guidelines and regulations.
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- EC Number:
- 291-443-0
- EC Name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- Cas Number:
- 90411-66-8
- IUPAC Name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino (otherwise not specified)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 200-280g bodyweight each.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5g/kg bw
- No. of animals per sex per dose:
- 5 males:5 females
- Control animals:
- no
- Details on study design:
- Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6, and 24 hours after treatment, and daily thereafter for a total of 14 days.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the observation period (14 days after dosing).
- Clinical signs:
- other: No effects observed.
- Gross pathology:
- No effects observed.
Any other information on results incl. tables
Observed mortality:
| Dose level (g/kg) | Sex | No. dead/No. Dosed (M:F) | Mortality (%) |
| 5 | 5M:5F | 0/5 : 0/5 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was determined to have a acute oral toxicity LD50 of >5000 mg/kg bw in the rat, under the conditions of the test.
- Executive summary:
Ten (5M:5F) albino rats, 200 -280g, each received a single dose of the test article at a dose level of 5g/kg bw. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6, and 24 hours adfter treatment, and daily thereafter for a total of 14 days. Non-survivors and animals surviving the 14 day obnservation period were subject to gross necropsy, with all findings noted. The test article was used as received (Sp.g. = 0.83).
LD50: 5 g/kg bw (5000 mg/kg bw)
This test article is not toxic orally to rats under the conditions of the test.
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