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Registration Dossier
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EC number: 203-385-5 | CAS number: 106-32-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The acute oral effects were investigated in rats by observation of the animals for a period of 2 weeks after a single dose.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Fasting period before study: 18 hours
- Diet: food was replaced in cages as soon as animals received their respective doses
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Information not available in the publication.
- No. of animals per sex per dose:
- 10 rats evenly divided by sex
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequent observations and weighing: yes
- Necropsy of survivors performed: no
- Evaluation: LD50, the slope function, and their confidence limits, together with toxic signs and times of death were recorded. - Statistics:
- LD50 were computed by the method of Litchfield and Wilcoxon (1949).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 43 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: This was the highest dose administered.
- Mortality:
- No animals died.
- Clinical signs:
- other: Depression and irritated gastro-intestinal tract. The animals appeared normal 24 hours after treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was 43 g/kg.
- Executive summary:
The acute oral toxicity effects of the test substances was assessed in rats. No specific guideline was followed. LD50, the slope function, and their confidence limits, together with toxic signs and times of death were recorded.
The highest dose administered was 43,000 mg/kg bw. The confidence limits were not determined.
No animals died, therefore the acute oral LD50 was 43 g/kg.
Toxic signs were depression and irritated gastro-intestinal tract. However, the animals appeared normal 24 hours after treatment.
As the LD50 > 2,000 mg/kg bw, the test item is not to be classified as acute toxic according to the CLP regulation.
43,000 mg/kg bw was the highest dose administered. The confidence limits were not determined.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- The acute oral effects were investigated in guinea pigs by observation the animals for a period of 2 weeks after a single dose.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Fasting period before study: 18 hours
- Diet: food was replaced in cages as soon as animals received their respective doses
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Information not available in the publication.
- No. of animals per sex per dose:
- Groups of 10 guinea-pigs consisting of both males and females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequent observations and weighing: yes
- Necropsy of survivors performed: no
- Evaluation: LD50, the slope function, and their confidence limits, together with toxic signs and times of death were recorded. - Statistics:
- LD50 were computed by the method of Litchfield and Wilcoxon (1949).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 24 190 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 19 350 - <= 30 240
- Mortality:
- Animals died between 4 hours and 6 days.
- Clinical signs:
- other: Depression and irritation of the gastro-intestinal tract.
- Other findings:
- The slope function was 1.5 (1.2 -2.0).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was 24.19 g/kg.
- Executive summary:
The acute oral toxicity effects of the test substances was assessed in guinea pigs. No specific guideline was followed, GLP was not indicated. LD50, the slope function, and their confidence limits, together with toxic signs and times of death were recorded.
The acute oral LD50 was calculated to be 24.19 g/kg, with 95% confidence limits: 19.35 - 30.24 g/kg.
The slope function was 1.5 (1.2 -2.0).
Toxic signs were depression and irritation of the gastro-intestinal tract.
As the LD50 > 2,000 mg/kg bw, the test item is not to be classified as acute toxic according to the CLP regulation.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Ethyl caprylate is mentioned in the report with ethyl pentanoate in between brackets. This makes it doubfull whether ethyl caprylate (= octanoate) or ethyl valerate (= pentanoate) was actually tested and therefore, the reliablity was set to 3 specifically for this test result.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The acute oral effects were investigated in rats by observation of the animals for a period of 2 weeks after a single dose.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Fasting period before study: 18 hours
- Diet: food was replaced in cages as soon as animals received their respective doses
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Information not available in the publication.
- No. of animals per sex per dose:
- 10 rats evenly divided by sex
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequent observations and weighing: yes
- Necropsy of survivors performed: no - Statistics:
- LD50 were computed by the method of Litchfield and Wilcoxon (1949).
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 25 960 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 22 190 - 30 370
- Mortality:
- Animals died between 4 hours and 4 days.
- Clinical signs:
- other: Depression, coma, wet posterior.
- Other findings:
- The slope function was 1.4 (1.2 - 1.6).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was 25.96 g/kg.
- Executive summary:
The acute oral toxicity effects of the test substances was assessed in rats. No specific guideline was followed, GLP was not indicated. LD50, the slope function, and their confidence limits, together with toxic signs and times of death were recorded.
The acute oral LD50 was calculated to be 25.96 g/kg, with 95% confidence limits: 22.19 - 30.37 g/kg.
The slope function was 1.4 (1.2 - 1.6).
Death times were 4 hours to 4 days.
Toxic signs were depression, coma and wet posterior.
As the LD50 > 2,000 mg/kg bw, the test item is not to be classified as acute toxic according to the CLP regulation.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1964
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The acute oral effects were investigated in rats by observation of the animals for a period of 2 weeks after a single dose.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl enantate
- EC Number:
- 203-382-9
- EC Name:
- Ethyl enantate
- Cas Number:
- 106-30-9
- Molecular formula:
- C9H18O2
- IUPAC Name:
- ethyl heptanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Fasting period before study: 18 hours
- Diet: food was replaced in cages as soon as animals received their respective doses
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Highest administered dose: 34640 mg/kg bw.
Unclear whether also lower doses were examined. - No. of animals per sex per dose:
- 5 male and 5 female rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequent observations and weighing: yes
- Necropsy of survivors performed: no - Statistics:
- LD50 were computed by the method of Litchfield and Wilcoxon (1949).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 34 640 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: This was the highest dose administered.
- Mortality:
- No animals died.
- Clinical signs:
- other: Depression, coma, rough and wet fur.
Any other information on results incl. tables
34640 mg/kg bw was the highest dose administered. The confidence limits were not determined.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was 34.64 g/kg.
- Executive summary:
The acute oral toxicity effects of the test substances was assessed in rats. No specific guideline was followed. GLP was not indicated. LD50, the slope function, and their confidence limits, together with toxic signs and times of death were recorded.
The highest dose administered was 34640 mg/kg bw. The confidence limits were not determined.
No animals died, therefore the acute oral LD50 was calculated to be 34.64 g/kg.
Toxic signs were depression, coma and a rough and wet fur.
As the LD50 > 2,000 mg/kg bw, the test item is not to be classified as acute toxic according to the CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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