Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998/04/28-1998/05/12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
other: EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (No L383A) Part B, Appendix B. 3., Acute Toxicity (dermal)
Principles of method if other than guideline:
There were no deviations from the protocol.
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar (Hsd/Win:WU/SPF
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, 33176, Borchen

- Weight at study initiation: 200-300g

- Fasting period before study:

- Housing: Makrolon Type 3 caages, each containing one rat. The bedding used was soft wood Type HW 300/500 W, produced by JELU-WERK, Ludwigsmuhle, 73494 Rosenberg.

- Diet: Ssniff R 10 diet in pellet form (laboratory standard rat diet), ad libitum, produced by Ssniff Spezialfutter GmbH, 59494 Soest

- Water: Tap water, ad libitum

- Acclimation period: Minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 +/- 3

- Humidity (%): 30-70 (temporary deviations were caused by cleaning the animal rooms

- 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: dorsolumbar region

- % coverage: 10

- Type of wrap if used: gauze, held in place with a semiocclusive dressing encircled firmly around the trunk


REMOVAL OF TEST SUBSTANCE

- Washing (if done): the treated area was cleaned with corn oil and absorbent paper

- Time after start of exposure: 24 hours


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 3.11 cm3/kg bw

- Concentration (if solution): undiluted

- Constant volume or concentration used: yes


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5M/5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Animals were observed ca. 30 minutes after dosing and at hourly intervals for the remainder of day 0 ( period of ca 6 hours). On the following 14 days animals were observed once daily and the nature of clinical signs observed were recorded at each observation.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The rats were checked at least twice daily for any mortalities. Thedermal response was observed once a day 24 h p.a. the first time and 14 days p.a. the last ti me. local dermal irritations as well as any other lesions were recorded. All animals were killed on day 14 by CO2 inhalation and subjected to macroscopic examination after opening the abdominal and thoracic cavities. The macroscopic appearance of all examined tissues was recorded for each animal.
Statistics:
No statistical analysis was carried out.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
There were no signs of systemic reaction to treatment.
Clinical signs:
After removal of the dressings 24 hours post application, until the end of the study no skin irritation was observed.
Body weight:
The male rats achieved satisfactory bodyweight gains throughout the study. Two female rats showed minimal bodyweight gain after the first week and one female rat after the second week. At the end of the study four female rats achieved satisfactory bodyweight gains. Variation of bodyweight in this age/bodyweight range is a physiological finding and not substance related.
Gross pathology:
The macroscopic examination on day 14 revealed no abnormalities.
Other findings:
No other findings reported.

Any other information on results incl. tables

The acute lethal dermal dose to rats of tetramethylsilane was found to be greater than 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 value of >2000 mg/kg bw in rats was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.