Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study with acceptable restrictions (only 2 animals per dose group, limited documentation and no information on purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Two male mice per dose were treated with 14.7, 21.5, 31.6 and 46.4 mL/kg bw test substance.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1-dimethoxycyclododecane
EC Number:
213-448-9
EC Name:
1,1-dimethoxycyclododecane
Cas Number:
950-33-4
Molecular formula:
C14H28O2
IUPAC Name:
1,1-dimethoxycyclododecane

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 46.4 mL/kg bw

Doses:
14.7, 21.5, 31.6 and 46.4 mL/kg bw (equivalent to 14.1, 20.6, 30.3 and 44.5 g/kg bw based on a relative density value of 0.96)
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs
Statistics:
LD50 was determined graphically.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
31.6 mL/kg bw
Based on:
test mat.
Remarks on result:
other: equivalent to 30.3 g/kg bw based on a relative density of 0.96
Mortality:
No mortality occurred at a dose level of 14.7 and 21.5 mL/kg bw. One animal died at a dose of 31.6 mL/kg bw. Two animals died in the highest dose group (46.4 mL/kg bw).
Clinical signs:
The following clinical signs were seen: sedation, ataxia, dyspnea, mydriasis, tremor, tonic cramps, abdominal position. Death occurred within 24 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study a LD50 value of 31.6 mL/kg bw (equivalent to 30.3 g/kg bw based on a relative density of 0.96) in male mice was found.