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Registration Dossier
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EC number: 221-906-4 | CAS number: 3277-26-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- It was not compliant with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Hexamethyldisiloxane
- EC Number:
- 203-492-7
- EC Name:
- Hexamethyldisiloxane
- Cas Number:
- 107-46-0
- Molecular formula:
- C6H18OSi2
- IUPAC Name:
- hexamethyldisiloxane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO
- Weight at study initiation: 180-200g
- Housing: in individual cages (37.5x17x15 cm)
- Diet: IFFARAT feed, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1C
- Humidity (%): 50 +/- 10
- Air changes (per hr): 8
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shaved dorsal skin
- Type of wrap if used: an aluminium sheet, held in place with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.62 ml/kg
- Duration of exposure:
- Single application, not rinsed
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5M, 5F
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- No statistical analysis reported in the study report.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: No skin reactions were noted during the exposure or over the 14 day observation period.
- Gross pathology:
- Not reported.
- Other findings:
- Not reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute dermal LD50 value of >2000 mg/kg was determined for male and female rats in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.
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