3-(trimethoxysilyl)propylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 20 Jan 2003 to 3 Feb 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

This study was conducted largely according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

observations only to 7 days, when effects still evident

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(trimethoxysilyl)propylamine

EC Number:

237-511-5

EC Name:

3-(trimethoxysilyl)propylamine

Cas Number:

13822-56-5

Molecular formula:

C6H17NO3Si

IUPAC Name:

3-(trimethoxysilyl)propylamine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA
- Age at study initiation: "young adult"
- Weight at study initiation: 3.018-3.171 kg
- Housing: 1/suspended wire mesh cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-19
- Humidity (%): 43.6-48.0. (The summary indicates the maximum humidity was 49.3%, the data provided do not appear to support this.)
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 2003-01-20 To: 2003-02-03 (14 days - although observational data are only given for 7 days)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat

Duration of treatment / exposure:

3 min
1 h
4 h

Observation period:

3-min: immediately and 1 (or 24) h
1-h: immediately and 24, 48, 73 h, and days 4 and 7
4-h: 1, 24, 48, 73 h, and days 4 and 7

Number of animals:

1 rabbit: 3-min, 1 h, 4 h
2 further rabbits: 4 h

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: not stated
- Type of wrap if used: 2-ply gauze secured with Micropore tape, overwrapped with gauze binder secured with Dermiform tape.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 3 min, 1 h, 4 h

SCORING SYSTEM: Draize, 1965. Mean of 1, 24, 48, 72 h

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 1, 24, 48, 72 h mean

Score:

1.8

Max. score:

8

Reversibility:

other: effects evident at 7 days, no data given after 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days, no data given after 7 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 days, no data given after 7 days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

4-Hour exposure caused erythema and oedema (grade 1 or 2) in up to three animals; erythema persisted to the final observation at 7 days. See tables 1-3.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal after exposure for 3 minutes, at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
Immediately after exposure	0	0
1 h*	0	0
Reversibility*	n/a	n/a

* the text describes a second observation at 1 h, the tabulated data describes the second observation at 24 h.

** Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Table 2: Irritant/corrosive response data for each animal after exposure for 1 hour, at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
Immediately after exposure	0	0
24 h	1	0
48 h	1	0
72 h	2^a	1
4 days	1	1
7 days	0^b	0
Reversibility*	c	n/a
Average time (unit) for reversion	7 days

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

a erythema spreading outside dosed site to

b = desquamation

Table 3: Irritant/corrosive response data for each animal after exposure for 4 hour, at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	0/1/0	0/0/0
24 h	1/2/1	0/2/1
48 h	1/2/1	0/1/0
72 h	2^a/2/1	1/1/1
4 days	2/1^b/1	1/1/1
7 days	0^b/1^b/1^b	0/0/0
Average 24 h, 48 h, 72 h (EU criteria)	1.3/2/1	0.3/1.3/0.7
Average 1 h, 24 h, 48 h, 72 h (as given in report); PII=1.8	1.2	0.6
Reversibility*	unclear	c
Average time (unit) for reversion	No data at 14 days	Day 7

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

a erythema spreading outside dosed site to

b = desquamation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted broadly in accordance with OECD 404 and GLP, found the test material to be slightly irritating to the skin of rabbits. According to EU criteria, classification as a skin irritant is required since the observed effects were not reversed at the end of the study.