N-[3-(triethoxysilyl)propyl]ethylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

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

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

EC Number:

225-806-1

EC Name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

Cas Number:

5089-72-5

Molecular formula:

C11H28N2O3Si

IUPAC Name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 4 months
- Weight at study initiation: 1.9 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. During exposure the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn.
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55± 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 June 2002 To: 22 Aug 2002

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin site served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

14 days; reading time points: 1, 24, 48, and 72 h after patch removal

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: Test site covered with a gauze patch, which was held in contact to the skin by means of a semi-occlusive dressing (non-irritating tape).

REMOVAL OF TEST SUBSTANCE
No residual test substance had to be removed.

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:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Erythema grade 1 (2/3 animals) and 2 (1/3 animals) were observed 60 min after patch removal. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch but were fully reversible within 24 h (2/3) and 72 h (1/3), respectively. Skin induration was observed in all 3 animals from day 4 until the end of the study. A dark brown discoloured application area was observed in one animal from 4 days to the end of the study. Peeling of the application site was observed in 3/3 animals after 9 days and persisted until the end of the study. Laceration of skin induration was observed in 1/3 animals at day 6, 7, and 9.

Any other information on results incl. tables

Table 1: Individual results of the skin irritation test.

Rabbit No.	1		2		3
Observation time	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	1	1	1	1	1
24 h	2	1	1	0	1	0
48 h	2	1	1	0	1	0
72 h	2	0	1	0	1	0
14 d	2 a,b,c	0	1 a,c	0	1 a,c	0
Mean value	2	0.66	1	0	1	0
24 + 48 + 72 h

a: skin induration

b: application site dark brown discoloured

c: peeling of the application site

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

A reliable study performed in accordance with OECD 404 and GLP found the test material to be irritating to the skin of rabbits. Erythema grade 1 (2/3 animals) and 2 (1/3 animals) were observed 60 min after patch removal. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch but were fully reversible within 24 h (2/3) and 72 h (1/3), respectively. Skin induration was observed in all 3 animals from day 4 until the end of the study. A dark brown discoloured application area was observed in one animal from 4 days to the end of the study. Peeling of the application site was observed in 3/3 animals after 9 days and persisted until the end of the study. Laceration of skin induration was observed in 1/3 animals at day 6, 7, and 9. No systemic effects were reported.