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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 Feb - 24 Feb 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted according to the appropriate OECD test guideline and in compliance with GLP. No data for analytical purity is reported. OECD TG 402: “A limit test at one dose level of at least 2000 mg/kg bodyweight may be carried out in a group of 5 male and 5 female animals.” Only 3 animals of each sex were treated with the test material in the present study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1981
Deviations:
yes
Remarks:
No data for analytical purity is reported. OECD TG 402: “A limit test at one dose level of at least 2000 mg/kg bodyweight may be carried out in a group of 5 male and 5 female animals.” Only 3 animals of each sex were used in the present study.
Qualifier:
according to guideline
Guideline:
other: EG 84/449/EWG
Version / remarks:
1984
Deviations:
yes
Remarks:
No data for analytical purity is reported. OECD TG 402: “A limit test at one dose level of at least 2000 mg/kg bodyweight may be carried out in a group of 5 male and 5 female animals.” Only 3 animals of each sex were used in the present study.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethoxyoctadecylsilane
EC Number:
221-339-2
EC Name:
Trimethoxyoctadecylsilane
Cas Number:
3069-42-9
Molecular formula:
C21H46O3Si
IUPAC Name:
trimethoxyoctadecylsilane

Test animals

Species:
rabbit
Strain:
other: White Russian
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 3 – 4 months (males), 4 months (females)
- Weight at study initiation: 2140 – 2310 g (males), 2060 – 2260 g (females)
- Housing: animals were caged individually in stainless-steel cages
- Diet: maintenance diet for rabbits (ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Fasting period before study: at the day of application with the test substance
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: shorn skin of the region between shoulder blade and sacrum
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and occluded with a piece of bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the treated skin was rinsed with water to remove any residual test item.
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 6 – 8 h after dosing and subsequently once daily thereafter
- Frequency of weighing: prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: yes
- Other examinations performed: external appearance, body orifices, body cavities (thoracic and abdominal) and their contents were examined macroscopically

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 was no mortality observed throughout the study period.
Clinical signs:
The test substance did not produce systemic toxic effects. The treated skin showed redness after removal of the test substance. Skin scales were observed between day 3 and day 7 post-application with the test substance, which were fully reversible within 13 days post-application.
Body weight:
All animals showed the expected body weight gains over the study period.
Gross pathology:
No abnormalities were detected at necropsy at the end of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no mortality occurred and no clinical signs of toxicity were observed. Skin scales were observed between day 3 and day 7 post-application with the test substance, which were fully reversible within 13 days post-application. Therefore, the test substance does not need to be classified for acute dermal toxicity according to Regulation (EC) No 1272/2008.