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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
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 levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
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.