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Toxicological information

Acute Toxicity: oral

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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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Mortality was observed from 4 h to 5 days after administration of test material.
Body weight:
No data
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.