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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:
2000-03-16 to 2000-03-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane
EC Number:
223-620-5
EC Name:
1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane
Cas Number:
3982-82-9
Molecular formula:
C28H32O2Si3
IUPAC Name:
1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 12 weeks old
- Weight at study initiation: 2308 - 2580 g
- Housing: the rabbits were housed individually in suspended metal cages.
- Diet: standard laboratory diet, SDS Stanrab (P) SQC rabbit diet, ad libitum. Autoclaved hay was supplied three times a week.
- Water: drinking water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 24.5°C
- Humidity (%): 20-38 %
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10 %
- Type of wrap if used: The treatment area was covered with porous gauze held with non-irritating dressing and further covered by waterproof dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes. The area was wiped with a towel moistened with water to remove any residual test substance.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.87 ml/kg
- Constant volume or concentration used: yes


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed twice daily for mortality. Individual weights were recorded on days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for clinical signs at 30 min and then approximately every hour on day 1, thereafter twice a day (morning and evening) until the end of the study period. The treated area of each animal was examined daily for erythema, eschar formation and oedema.
Statistics:
Group mean body weights and body weight changes were calculated using appropriate means.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths observed
Mortality:
No mortality occurred during the 14-day study period.
Clinical signs:
No clinical signs of toxicity were observed in any of the test animals.
Body weight:
Weight loss was evident in 2 females on day 8, and in another female on days 8 and 15. The expected body weight gain was observed in the majority of the animals.
Gross pathology:
Gaseous distension in the large intestine was noted in one female at necropsy. No macroscopic abnormalities were observed in the rest of the animals.
Other findings:
There were no dermal reactions observed throughout the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study, the reported LD50 value for 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane was >2000 mg/kg bw in rabbits.