Undecan-4-olide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1964

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment. Substance purity is not mentioned.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no details on test animals and environmental conditions; no details on results

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Undecan-4-olide

EC Number:

203-225-4

EC Name:

Undecan-4-olide

Cas Number:

104-67-6

Molecular formula:

C11H20O2

IUPAC Name:

5-heptyloxolan-2-one

Details on test material:

- Name of test material (as cited in study report): Aldehyde C-14 (γ-undecalactone)

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: young adult
- Weight at study initiation: no data
- Fasting period before study: approximately 18 hours
- Housing: divided by sex
- Diet (e.g. ad libitum): ad libitum, except during administration of test material
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

No data

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

Method of Litchfield and Wilcoxon (1949)

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

18 500 mg/kg bw

Based on:

test mat.

95% CL:

16 930 - 20 260

Mortality:

Mortality was observed from 4 h to 5 days after administration of test material.

Clinical signs:

other: Mortality was observed from 4 h to 5 days after administration of test material.

Gross pathology:

No data

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for Aldehyde C-14 (γ-undecalactone) is higher than 5000 mg/kg bw in rats. Therefore it is not classified according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute oral toxicity study, groups (5/sex) of Osborne-Mendel rats were given a single oral dose of Aldehyde C-14 (γ-Undecalactone) by oral intubation. Animals were then observed for mortality and clinical signs for 2 weeks. LD50 was calculated using the method of Litchfield & Wilcoxon (1949).

Mortality was observed from 4 h to 5 days after administration of test material. Depression occurred within 10 minutes and wet fur was noticed.

Oral LD50 Combined = 18500 mg/kg bw (16930-20260).

Under the test conditions, the oral LD50 for γ-Undecalactone is higher than 5000 mg/kg bw in rats and therefore it is not classified according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.