1,4-dioxacycloheptadecane-5,17-dione

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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, the result was non-toxic at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 402. 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:

A single dermal dose of test material was applied to the skin of 10 rabbits

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:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

none

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

no data

Duration of exposure:

no data

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

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

not specified

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred during the study

Clinical signs:

other: no data

Gross pathology:

no data

Other findings:

Skin irritation:
- Slight redness: 5/10
- Moderate redness: 3/10
- Slight edema: 1/10
- Moderate edema: 1/10

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:

LD50 > 5000 mg/kg bw

Executive summary:

In a limit acute dermal toxicity study, 10 rabbits were exposed to the test material at dose of 5000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions for 14 days.

 

No mortality occurred during the study.

Skin irritation was observed in the animals: 5/10 had slight redness, 3/10 moderate redness, 1/10 slight erythema, 1/10 moderate erythema.

 

Dermal 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 of the Directive 67/548/EEC.

Even if only few details were available on method used in this study, the result was "non-toxic at 5000 mg/kg bw" which is 2.5 times more than is needed for the OECD 402. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover the acute dermal toxicity endpoint.