Bis(triethoxysilylpropyl)amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 Nov 2008 - 29 Jan 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(triethoxysilylpropyl)amine

EC Number:

236-818-1

EC Name:

Bis(triethoxysilylpropyl)amine

Cas Number:

13497-18-2

Molecular formula:

C18H43NO6Si2

IUPAC Name:

bis(triethoxysilylpropyl)amine

Test animals

Species:

rat

Strain:

other: Crl:CD (SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: 50 days (males), 64 days (females)
- Weight at study initiation: 218-240 g (males), 205-222 g (females)
- Fasting: 16 h prior to dosing
- Housing: individual housing in Makrolon cages (type III plus)
- Diet: ssniff R/M-H V1534, ssniff Spezialdiäten GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- 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: 5 cm x 6 cm
- % coverage: 10% of total body surface
- Type of wrap if used: gauze bandaging (8 layers) covered with a plastic sheet and secured with adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period no residual test item had to be removed

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, 2.07 mL/kg

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: The rats were observed before and immediately, 5, 15, 30, and 60 min as well as 3, 6, and 24 h post-dose (clinical signs and mortality). Body weights were obtained before treatment and weekly thereafter.
During the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern, were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

- Necropsy of survivors performed: yes (At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. No histopathology was carried out as no macroscopical findings were noted at autopsy.)
- Dermal observations: application sites were examined for erythema, oedema and other dermal findings once daily until the end of the observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

The macroscopic examination did not reveal any changes.

Other findings:

- Other observations: No skin reactions were observed at the application site in any animals at any time point.

Any other information on results incl. tables

Table 1: Body weights of the animals in the acute dermal toxicity study.

Dose group [mg/kg bw]		BW±SD [g]
		day 0	day 7	day 14
2000	male	226.6	299±32	337.6±49
2000	female	212.4	248.2±16.9	258.6±21.8

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 conducted according to OECD 402 and in compliance with GLP, a LD50 of > 2000 mg/kg bw was derived for rats. No mortality and no clinical signs of toxicity were observed. The body weight gain was not influenced by the test item administration. The macroscopic examination did not reveal any changes. No skin reactions were observed at the application site in any animal at any time point.