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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Oxacycloheptadecan-2-one is not acutely toxic by oral and dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Ten rats (sex unknown) were orally exposed to oxacycloheptadecan-2-one at 5,000 mg/kg bw. Rats were observed for 14 days, clinical signs were noted.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No details given.
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Rats were found to be slightly lethargic (no further details given).
Interpretation of results:
GHS criteria not met
Conclusions:
Ten rats (sex unknown) were orally exposed to 5,000 mg oxacycloheptadecan-2-one/kg bw. During the observaton period of 14 days, no mortality occurred. Rats were found to be slightly lethargic. Based on this data it can be concluded that the oral LD50 of oxacycloheptadecan-2-one exceeds 5000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
2 (limited reporting, but the study is performed by a well-known testing lab and is considered reliable).

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Four rabbits (sex unknown) were exposed to 2500 mg/kg bw, six rabbits (sex unknown) were exposed to 5000 mg/kg bw. Rabbits were observed for 14 days for mortality, skin effects were documented.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
No further details given.
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No further details given.
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
No data
Doses:
2500 and 5000 mg/kg bw
No. of animals per sex per dose:
4 (2500 mg/kg bw), 6 (5000 mg/kg bw)
Control animals:
no
Details on study design:
Observation period of 14 days.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Duration of exposure not specified.
Mortality:
One rabbit in high dose group died on day 5.
Clinical signs:
Skin irritation was observed:
Slight redness: 4/10
Moderate redness: 4/10
Slight edema: 4/10
Moderate edema: 4/10
Body weight:
No data
Gross pathology:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
Four rabbits were dermally exposed to 2500 mg oxacycloheptadecan-2-one/kg bw, 6 rabbits were exposed to 5000 mg oxacycloheptadecan-2-one/kg bw. During the observation time of 14 days, one rabbit (exposed to 5000 mg/kg bw) dies on day 5. Skin irritation was observed in several rabbits (slight and moderate redness (in 4/10 each), slight and moderate edema (in 4/10 each). These data indicate that the dermal LD50 of oxacycloheptadecan-2-one exceeds 5000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
2 (limited reporting, but the study is performed by a well-known testing lab and is considered reliable).

Additional information

In a study predating GLP and modern guidelines, oxacycloheptadecan-2-one has been administered orally or dermally to a group of 10 rats of unspecified sex and strain at a limit dose of 5000 mg/kg bw. Animals were observed for 14 days for mortality and clinical signs. There were no deaths, and no clinical signs were noted. Based on the results of the study, the acute oral and acute dermal LD50 values of oxacycloheptadecan-2-one both exceed 5000 mg/kg bw.

Justification for classification or non-classification