1,4-dioxacycloheptadecane-5,17-dione

Acute Toxicity: oral

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-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:

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

Test material information

Constituent 1

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.