Triethoxyhexadecylsilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 - 24 Aug 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

(1998)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(2008)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxyhexadecylsilane

EC Number:

240-465-9

EC Name:

Triethoxyhexadecylsilane

Cas Number:

16415-13-7

Molecular formula:

C22H48O3Si

IUPAC Name:

triethoxy(hexadecyl)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: Charles River, Sulzfeld, Germany
- Age at study initiation: 10 - 11 weeks (males), 13 - 14 weeks (females)
- Weight at study initiation: 249 - 276 g (males), 200 - 209 g (females)
- Housing: animals were kept individually in IVC cages (type III H), polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30 Jul 2015 To: 24 Aug 2015

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: the test item was applied on the back of the animals
- % coverage: not less than 10% of body surface
- Type of wrap if used: the test item was held in contact with the skin with a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using aqua ad injectionem
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination was made several times on the day of dosing and once daily thereafter, weighing was performed prior to application and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical examination included changes in the skin/fur, edema and erythema, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortalities occurred during the entire study period.

Clinical signs:

other: No signs of systemic toxicity were recorded during the entire study period.

Gross pathology:

Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were found in any animal.

Other findings:

No erythema or edema was observed in any animal during the entire study period. Scratches were observed in 1/5 male animals, which were considered as slight signs of irritation. All signs of irritation were reversible within the observation period.

Any other information on results incl. tables

Table 1: Absolute Body Weights in g and Body Weight Gain in %

Test Group	Animal No.	Dose (mg/kg bw)	Body Weight (g) on Day			BW gain in Comparison to Day 1 (%)
			Day 1	Day 8	Day 15	Day 15
Males	21	2000	260	265	294	13
	22		249	255	277	11
	23		270	280	316	17
	24		276	288	321	16
	25		272	280	312	15
Females	26	2000	203	204	210	3
	27		206	202	218	6
	28		209	212	226	8
	29		206	206	214	4
	30		200	200	213	7

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 an acute dermal toxicity study according to OECD TG 402 and in compliance with GLP, no mortality and no clinical signs of toxicity were observed at the limit dose of 2000 mg/kg bw. Furthermore, no erythema and edema were observed within the 14 day observation period. In conclusion, a dermal LD50 value >2000 mg/kg bw was derived.