3-(diethoxymethylsilyl)propylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21.11.1989 to 12.12.1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study conducted in accordance with the OECD guideline but without GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

none evident based on translation of German report

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(diethoxymethylsilyl)propylamine

EC Number:

221-660-8

EC Name:

3-(diethoxymethylsilyl)propylamine

Cas Number:

3179-76-8

Molecular formula:

C8H21NO2Si

IUPAC Name:

(3-aminopropyl)diethoxymethylsilane

Details on test material:

- Name of test material (as cited in study report): DYNASYLAN 1505 (3-aminopropyl)diethoxymethylsilan
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:

rabbit

Strain:

other: White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomas GmbH, Biberach, GERMANY
- Age at study initiation: not stated
- Weight at study initiation: 2.4 kg
- Housing: not identified from report in German
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1
- Humidity (%): 60 +/-5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: not clear. Test began 1989-11-21 and ended 1989-12-12

Test system

Type of coverage:

other: covered application. It is not clear from the German report whether the material used was occlusive or semi-occlusive. If the study followed OECD 404, as indicated, it would have been semi-occlusive.

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 cm3

Duration of treatment / exposure:

4 h (1h, 3 minutes - no further details)

Observation period:

observed at 1, 24, 48, 73 h following 4-h exposure. No 14-day follow-up observation due to corrosive effects.

Number of animals:

1 (No details are given on additional animals, if any, used for the 1-h and 3-minute exposures. )

Details on study design:

TEST SITE
- Area of exposure: Dorsal
- % coverage: not stated
- Type of wrap if used: unclear from German report

REMOVAL OF TEST SUBSTANCE
- Washing: gently rinsed with warm water
- Time after start of exposure: 4h.

SCORING SYSTEM: grading according to OECD 404.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Remarks:

erythema and oedema

Basis:

animal #1

Remarks:

exposure for 4 h

Time point:

other: 24, 48 and 72 h (mean)

Score:

8

Max. score:

8

Reversibility:

not reversible

Irritant / corrosive response data:

4-h exposure caused immediate grade 4/4 oedema and erythema in the single animal tested at all observation times following treatment (1, 24, 48 and 72 h). Necrosis and hardened skin were also reported. Due to the severe corrosive effects the observation was stopped at 72 hours. Exposure for 1 h also resulted in necrosis, but exposure for 3 minutes did not. Full data are not given for these shorter exposure periods.

Other effects:

None stated

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.

Score at time point / Reversibility	Erythema	Edema	Necrosis	Hardening of skin
	Max. score: 4	Max. score: 4
1 h	4	4	yes
24 h	4	4	yes	yes
48 h	4	4	yes	yes
72 h	4	4	yes	yes
Average 24h, 48h, 72h	4	4
Average 1h, 24h, 48h, 72h	4	4

Reversibility not assessed as study terminated at 72 h due to corrosive effects.

Based on single animal exposed for 4 h.

 

Applicant's summary and conclusion

Interpretation of results:

other: Likely to be Cat 1B

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In a skin irritation/corrosion study conducted in accordance with OECD 404 but not GLP (reliability score 2), the test substance was found to be corrosive to the skin of a single rabbit (grade 8/8) following a 4-hour exposure. Necrosis was also observed following a 1-hour but not a 3-minute exposure (extremely limited details on the 1-hour and 3 minute exposures).