Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxy(2,4,4-trimethylpentyl)silane
EC Number:
252-558-1
EC Name:
Triethoxy(2,4,4-trimethylpentyl)silane
Cas Number:
35435-21-3
Molecular formula:
C14H32O3Si
IUPAC Name:
triethoxy(2,4,4-trimethylpentyl)silane
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: 200-300 g
- Fasting period before study: Not stated.
- Housing: Individually in Macrolon cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 'Adequate'. Period not stated.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 55 ±10
- Air changes (per hr): at least 10
- 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: Not stated
- % coverage: At least 10% of total body surface
- Type of wrap if used: Semi-occlusive gauze dressing and non-irritating tape, with a bandage that wrapped around the abdomen.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with water
- Time after start of exposure: 24 hours.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Constant volume or concentration used: no data



Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed prior to application of test substance and on Day 7 and 15. Cageside observations were made several times per day on the day of application and once per day thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination following necropsy.
Statistics:
No statistics were performed.

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:
There were no deaths.
Clinical signs:
No clinical signs were observed.
Body weight:
Weight gain of the male animals was within the expected range. The female animals lost weight within the first week after application, but had a normal weight gain during the second week. This was probably due to the stress of the manipulation procedure, which means a big physical strain for the animals. This was more visible for the female animals because they had already reached their adult weights at the beginning of the study.
Gross pathology:
There were no findings.
Other findings:
No other findings were reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute dermal toxicity study, conducted according to OECD Test Guideline 402 and in compliance with GLP, the LD50 for triethoxy(2,4,4-trimethylpentyl)silane was concluded to be > 2000 mg/kg bw.