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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-08-01 to 1986-08-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane
EC Number:
253-973-0
EC Name:
12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane
Cas Number:
38495-30-6
Molecular formula:
C16H36O8Si
IUPAC Name:
12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna (UK) Limited
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: males 125 -152 g, females 127 - 147 g
- Fasting period before study: overnight before dosing and 2 hours after dosing
- Housing: in polypropylene cages
- Diet: Rat and Mouse Expanded Diet No. 1, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 60-70 %
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.94 ml/kg


Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made at 1 and 4 hours after administration, and then daily for 14 days; body weights were recorded on the day of the treatment (day 0), and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight
Statistics:
No statistics were used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the 14-day study period.
Clinical signs:
other: Hunched posture, pilo-erection and decreased respiratory rate were observed in all treated animals at 1 and 4 hours post-administration. Additionally, lethargy was noted in 5 out of 10 animals, as well as ataxia in 4 out of 10 animals at 1 and 4 hours aft
Gross pathology:
No abnormalities were observed at necropsy at the end of the study period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the acute oral toxicity study, conducted according to OECD TG 401, and in compliance with GLP, an LD50 value of > 2000 mg/kg bw was reported for 12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane.