Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
(1998)
Deviations:
no
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

Constituent 1
Chemical structure
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:
No signs of systemic toxicity were recorded during the entire study period.
Body weight:
A slight weight loss was recorded for 1/5 female animals during the first week, but all of the female animals showed weight gain during the second week. The male animals showed normal weight gain during the first and the second week of the observation 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.