N-[3-(trimethoxysilyl)propyl]aniline

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(trimethoxysilyl)propyl]aniline

EC Number:

221-328-2

EC Name:

N-[3-(trimethoxysilyl)propyl]aniline

Cas Number:

3068-76-6

Molecular formula:

C12H21NO3Si

IUPAC Name:

N-[3-(trimethoxysilyl)propyl]aniline

Details on test material:

- Name of test material (as cited in study report): SILQUEST Y-9669 Silane
- Physical state: clear colourless liquid
- Analytical purity: 99.4%
- Lot/batch No.: 16166-67
- Storage condition of test material: original container at room temperature

Test animals

Species:

rat

Strain:

other: Crl:CD BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI, USA
- Age at study initiation: young adult
- Weight at study initiation: 220-267 g
- Fasting: 18-20 h prior to dosing until 3-4 after dosing
- Housing: individual housing in mesh-bottom cages
- Diet: Purina Certified Rodent Chow #5002, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1±0.2
- Humidity (%): 39.1-44.0
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: 14-18% of total body surface
- Type of wrap if used: gauze bandaging secured with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): application sites were wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, 1.92 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 1, 3, and 4 h post-dose on day of appplication (day 0) and once daily (clinical observation) or twice daily (mortality) thereafter. Body weights were obtained on the day of treatment and on days 7 and 14.
- Necropsy of survivors performed: yes (major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals)
- Dermal observations: application sites were examined for erythema, oedema and other dermal findings 30-60 minutes after bandage removal and daily thereafter for thirteen days. The rats were clipped to facilitate dermal observations on study days 7 and 14.

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: Clinical findings were limited to dried red material around the eye(s) and/or nose for seven rats and wet and dried yellow urogenital staining for five rats. These findings are typically noted in association with the bandage/collar application procedures

Gross pathology:

Reddened seminal vesicles and multiple calculi in the kidneys, ureter(s) and urinary bladder were noted in one male at the terminal necropsy. These are common, spontaneous findings in rats of this age and strain and were unrelated to the test material. One female had scabbing on the application site. There were no other gross necropsy findings for all examined tissues.

Other findings:

- Other observations:
The test material induced very slight to severe erythema, very slight edema and eschar on one animal. Desquamation was present on six animals. There were no other dermal findings. With the exception of one male and female with severe erythema, slight edema, eschar and/or desquamation, all dermal irritation completely subsided by day 11 or earlier. Skin reactions were determined using the Draize scoring system.

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	262±4	304±12	343±23
2000	female	225±4	225±5	235±6

Table 2: Dermal observations of the males in the acute dermal toxicity study.

Rat No. (males)	1		2		3		4		5
Observation time [day no]	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	0d	0	0d	0	0	0	0	0	0	0
2	0d	0	0	0	0	0	0	0	0	0
3	0d	0	0	0	0	0	0	0	0	0
4	0d	0	0d	0	0	0	0	0	0d	0
5	0d	0	0d	0	0	0	0	0	0d	0
6	0d	0	0	0	0	0	0	0	0	0
7	0d	0	0	0	0d	0	0	0	0	0
8	0d	0	0	0	0d	0	0	0	0	0
9	0d	0	0	0	0d	0	0	0	0	0
10	0d	0	0	0	0d	0	0	0	0	0
11	0d	0	0	0	0	0	0	0	0	0
12	0d	0	0	0	0	0	0	0	0	0
13	0d	0	0	0	0	0	0	0	0	0
14	0d	0	0	0	0	0	0	0	0	0

d: desquamation

Table 3: Dermal observations of the females in the acute dermal toxicity study.

Rat No. (females)	1		2		3		4		5
Observation time [day no]	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	0	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0
3	0	0	0d	0	0	0	0	0	0	0
4	0	0	0d	0	0	0	0	0	0d	0
5	0	0	1d	0	0	0	0	0	0	0
6	0	0	1d	0	0	0	0	0	0	0
7	0	0	2d	0	0	0	0	0	0	0
8	0	0	2d	0	0	0	0	0	0	0
9	0	0	3d	1	0	0	0	0	0	0
10	0	0	3d	1	0	0	0	0	0	0
11	0	0	4de	1	0	0	0	0	0	0
12	0	0	4de	1	0	0	0	0	0	0
13	0	0	4de	1	0	0	0	0	0	0
14	0	0	4de	1	0	0	0	0	0	0

d: desquamation

e: eschar

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