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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-guideline and pre-GLP study. Only basic data given. However, only one death and slight lethargy were observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.
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:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Principles of method if other than guideline:
10 rats were treated with a single dose of 5000 mg/kg bw and observed for a 14-day period
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-dioxacycloheptadecane-5,17-dione
EC Number:
203-347-8
EC Name:
1,4-dioxacycloheptadecane-5,17-dione
Cas Number:
105-95-3
Molecular formula:
C15H26O4
IUPAC Name:
1,4-dioxacycloheptadecane-5,17-dione
Test material form:
not specified
Details on test material:
none

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
none

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
none
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no data
Statistics:
none

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
one animal died on day 1
Clinical signs:
other: Rats were slightly lethargic
Gross pathology:
no data
Other findings:
none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 > 5000 mg/kg bw
Executive summary:

In a limit acute oral toxicity study, 10 rats were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality for 14 days.

 

One animal died on Observation Day 1. No other mortality occurred during the study. Rats were slightly lethargic.

 

Oral LD50 > 5000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and the Directive 67/548/EEC.

Even if only few details were available on method used in this study, only one death and slight lethargy were observed at the dose level of 5000 mg/kg bw which is 2.5 times more than is needed for the OECD 401. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover the acute dermal toxicity endpoint.