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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Standard tox study design
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
EC Number:
219-154-7
EC Name:
2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
Cas Number:
2374-14-3
Molecular formula:
C12H21F9O3Si3
IUPAC Name:
2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Langshaw Farms, Augusta, Michigan
- Age at study initiation: approx 5 weeks old
- Weight at study initiation: not stated
- Housing: standard stainless steel cages
- Diet: PURINA Rabbit Chow (ad libitum)
- Water: fresh water (ad libitum)
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 50-60
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated

IN-LIFE DATES: From: To: not stated

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on exposure:
TEST SITE
- Area of exposure: not stated
- % coverage: not stated
- Type of wrap if used: impervious sleeve of plastic material
- Time intervals for shavings or clippings: at least 24 hours before initial application, as needed thereafter

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water
- Time after start of exposure: 6 hours

TEST MATERIAL
- Amount applied (volume or weight with unit): not stated
- Concentration: 100%
- Constant volume or concentration used: not stated

USE OF RESTRAINERS FOR PREVENTING INGESTION: no
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
6 hours per day
Frequency of treatment:
5 days per week for 3 weeks
Doses / concentrationsopen allclose all
Dose / conc.:
40 mg/kg bw/day (nominal)
Dose / conc.:
200 mg/kg bw/day (nominal)
Dose / conc.:
400 mg/kg bw/day (nominal)
No. of animals per sex per dose:
6
Control animals:
yes, sham-exposed

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least twice daily after application of test material

DETAILED CLINICAL OBSERVATIONS: No data

DERMAL IRRITATION (if dermal study): No data

BODY WEIGHT: Yes
- Time schedule for examinations: Day 1, 4, 8, 12, 16 and 21

FOOD CONSUMPTION: Yes
- Time schedule for examinations: Day 1, 4, 8, 12, 16 and 21

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination
- Anaesthetic used for blood collection: Yes (methoxyflurane)
- Animals fasted: No data
- How many animals: All
- Parameters not stated

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at termination
- Animals fasted: No data
- How many animals: All
- Parameters not stated

URINALYSIS: Yes
- Time schedule for collection of urine: for 16 hours prior to termination
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters not stated

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes, performed on all major tissues, organs, orifices, cranial, thoracic, abdominal and pelvic cavities and their viscera.
ORGAN WEIGHT: A complete set of organs and tissues were weighed
HISTOPATHOLOGY: Yes, a complete set of organs and tissues were removed and preserved.
Statistics:
Statistical comparisons between control and test groups were carried out where applicable. The data were analysed by employing Dunnett multiple t-test. Where appropriate, a non-parametric analysis of variance by ranks was used to evaluate these parameters. The 95% (p<0.05) confidence level was used as the criteria of significance.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
There were no remarkable clinical signs. Three male and 2 females died during the treatment period at 400 mg/kg/day. One female at 200 mg/kg/day died as a result of acute pneumonia.
Dermal irritation:
not specified
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Significant reduction in body weight gain was noted for females at 200 and 400 mg/kg/day, similar, but less marked, effects on body weight were noted for males at the same doses.
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Lower food consumption was recorded at 200 and 400 mg/kg/day during the treatment period.
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Description (incidence and severity):
There was no effect of treatment.
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
Serum alkaline phosphatase activity was significantly lower at 200 or 400 mg/kg/day. Significantly higher serum glutamic-pyruvic transaminase and serum glutamic oxalacetic transaminase were noted in males at 200 or 400 mg/kg/day. For females, only serum glutamic oxalacetic transaminase was higher at 200 mg/kg/day.
Urinalysis findings:
no effects observed
Description (incidence and severity):
There was no effect of treatment.
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Relative liver weight was lower in females at all doses and to a lesser extent males.
Gross pathological findings:
no effects observed
Description (incidence and severity):
No remarkable findings.
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No effect of treatment.
Histopathological findings: neoplastic:
no effects observed

Effect levels

Dose descriptor:
NOAEL
Effect level:
40 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Target system / organ toxicity

Critical effects observed:
yes
Lowest effective dose / conc.:
200 mg/kg bw/day (actual dose received)
System:
gastrointestinal tract
Organ:
liver
Treatment related:
yes
Dose response relationship:
yes
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
Dermal administration of 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane to rabbits at 40, 200 or 400 mg/kg bw/day (5 days a week for 3 weeks) resulted in mortality at 400 mg/kg bw/day and lower body weight gain, food consumption, serum alkaline phosphatase activity and relative organ weight and increased serum glutamic-pyruvic transaminase and glutamic oxalacetic transaminase at 200 and 400 mg/kg bw/day. The no-observed-adverse-effect-level was considered to be 40 mg/kg bw/day.