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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Oxacycloheptadecan-2-one
EC Number:
203-662-0
EC Name:
Oxacycloheptadecan-2-one
Cas Number:
109-29-5
Molecular formula:
C16H30O2
IUPAC Name:
oxacycloheptadecan-2-one
Test material form:
not specified
Details on test material:
Sample marking: 74-206 HEXADECANOLIDE
Specific details on test material used for the study:
No further details given.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No further details given.

Administration / exposure

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.

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.