Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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 for cross-reference:
reference to same study
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

Constituent 1
Chemical structure
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.