Trimethoxyoctadecylsilane

Acute Toxicity: dermal

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 guideline

Test guideline 1

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.

Test guideline 2

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

Test material information

Constituent 1

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.