N-[3-(trimethoxysilyl)propylcyclohexylamine]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 - 28 Apr 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(1984)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(trimethoxysilyl)propylcyclohexylamine]

EC Number:

221-329-8

EC Name:

N-[3-(trimethoxysilyl)propylcyclohexylamine]

Cas Number:

3068-78-8

Molecular formula:

C12H27NO3Si

IUPAC Name:

N-[3-(trimethoxysilyl)propyl]cyclohexanamine

Details on test material:

- Name of test material (as cited in study report): Organofunctional Silane A-1128
- Physical state: clear yellow-brown viscous liquid
- Expiration date of the lot/batch: 31 Aug 1993
- Storage condition of test material: at room temperature, dry in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 12 weeks
- Weight at study initiation: 2198 - 2452 g
- Housing: animals were housed individually in labelled cages with perforated floors
- Diet: approximately 100 g/day standard laboratory rabbit diet LKK-20 (Hope Farms, Woerden, The Netherlands), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

7 days
Reading time points: 45 min, 24, 48 and 72 h and 7 days

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2 x 3 cm
- Type of wrap if used: A surgical gauze patch mounted on Micropore tape was used, the dressing was wrapped around the abdomen and secured with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: 4 h after the application the dressing was removed and residual test material was removed using a tissue moistened with tap water and subsequently a dry tissue.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Forty-five minutes after exposure to the test material, very slight (grade 1) or well defined erythema (grade 2) and very slight (grade 1) or slight edema (grade 2) were observed in the treated skin areas in 3/3 animals. The erythema persisted for 72 h and had resolved in 3/3 animals within 7 days after exposure to the test material. The edema had resolved within 48 h in 2/3 animals and within 72 h in 1/3 animal after exposure with the test material. No evidence of a corrosive effect was observed on the skin.

Other effects:

No symptoms of systemic toxicity were observed in the animals during the study period and no mortality occurred.

Any other information on results incl. tables

Table 1: Individual skin irritation scores

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
45 min	2	1	1	1	2	2
24 h	2	1	1	2	2	1
48 h	2	0	1	1	2	0
72 h	1	0	1	0	1	0
Mean value 24 + 48 + 72 h	1.67	0.33	1	1	1.67	0.33

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 a primary skin irritation/corrosion study according to OECD guideline 404 and in compliance with GLP, three male New Zealand White rabbits were exposed to the test material for 4 h under semi-occlusive dressing. In conclusion, the test material can be considered as non-irritant under the conditions of the test.