N-[3-(methoxydimethylsilyl)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, Germany

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(methoxydimethylsilyl)propyl]ethylenediamine

EC Number:

221-337-1

EC Name:

N-[3-(methoxydimethylsilyl)propyl]ethylenediamine

Cas Number:

3069-33-8

Molecular formula:

C8H22N2OSi

IUPAC Name:

(2-aminoethyl)[3-(methoxydimethylsilyl)propyl]amine

Details on test material:

- Name of test material (as cited in study report): VP 50991
- Physical state: colourless liquid
- Storage condition of test material: at room temperature, dry, tightly closed, dark

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: 1.6 - 2 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

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:

mean

Remarks:

out all all three animals

Time point:

other: mean over 24, 48, and 72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all three animals

Time point:

other: mean over 24, 48, and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Erythema grade 3 were observed in all 3 animals from 60 min to 14 days after exposure. Very slight oedema reactions (grade 1) were observed in all 3 animals 60 min after removal of the patch. Oedema reactions were fully reversible within 24 h in all 3 animals. A pale yellow or light-red bordered application site was observed in all animals 24 h after exposure until the end of the 14 day observation period. Necrosis at the application site was observed after 72 h (2/3 animals) or 4 days (1/3 animals) after patch removal. Peeling of the application site was observed in 2/3 animals after 14 days.

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	3	1	3	1	3	1
24 h	3 a,b	0	3 a,b	0	3 a,b	0
48 h	3 a,b	0	3 a,b	0	3 a,b	0
72 h	3 a,b,c	0	3 a,b,c	0	3 a,b	0
14 d	3 a,b,c	0	3 a,b,c,d	0	3 a,b,c,d	0
Mean value	3	0	3	0	3	0
24 + 48 + 72 h

a: skin induration

b: application site (pale) yellow or light-red bordered

c: necrosis of the whole application site

d: peeling of the application site

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study performed in accordance with OECD 404 and GLP found the test material to be corrosive to the skin of rabbits. Erythema mean scores of 3 were observed and were not reversible within the observation period. Oedema mean scores were 0 for all animals. Necrosis at the application site was observed 3 days after patch removal in all animals respectively.