Registration Dossier
Registration Dossier
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EC number: 223-620-5 | CAS number: 3982-82-9
Acute Toxicity: dermal
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:
- 2 000
- 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
- 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
Constituent 1
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.
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