3-diethylaminopropiononitrile

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: Guideline study, GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-diethylaminopropiononitrile

EC Number:

226-323-9

EC Name:

3-diethylaminopropiononitrile

Cas Number:

5351-04-2

Molecular formula:

C7H14N2

IUPAC Name:

3-(diethylamino)propanenitrile

Details on test material:

- Name of test substance (as cited in study report): N,N-Diethylaminopropionitril
- Analytical purity: 99.6%
- Test substance number: 96/119
- Batch number: K80/1 Hauptlauf
- Physical state: liquid (colourless)
- Storage conditions: refrigerator

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, UK
- Age at study initiation: young adult animals
- Weight at study initiation: 3.5 kg and 3.64 kg (males); 4.0 kg (female)
- Housing: single housing in stainless stel wire mesh cages with grating, floor area 3000 cm²
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugust, Switzerland; about 130 g per animal per day
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- 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 site of the animal served as control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 h (readings: 1 h, 24 h, 48 h and 72 h after application)
A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and fixomull stretech (adhesive fleece) (Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: evaluation was performed according to the Draize Scoring System

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(out of all 3 animals)

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(out of all 3 animals)

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

Table 1: Skin irriation

Reading	Animal#	Erythema	Edema	Symptoms
1 h	1	2	2	a, b
	2	2	1	a, b
	3	2	2	a, b
24 h	1	1	0	a
	2	1	0	a
	3	1	0	a
48 h	1	0	0
	2	0	0
	3	0	0
72 h	1	0	0
	2	0	0
	3	0	0
Mean	1	0.33	0.00
	2	0.33	0.00
	3	0.33	0.00
Mean		0.33	0.00

a = erythema extending beyond the area of exposure

b = edema extending beyond the area of exposure

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information