N,N-bis(2-methylpropyl)formamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-04-11 to 1988-04-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(2-methylpropyl)formamide

EC Number:

219-983-4

EC Name:

N,N-bis(2-methylpropyl)formamide

Cas Number:

2591-76-6

Molecular formula:

C9H19NO

IUPAC Name:

N,N-bis(2-methylpropyl)formamide

Details on test material:

Name of the test substance used in the study report: Diisobutylformamid
- Purity: Please refer to section 1.2 for purity information.

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Weight at study initiation: 2.77
- Housing: Single housing in stainless steel cages with wire mesh walk floors (floor area: 40 cm x 51 cm).
- Diet: Standardized animal laboratory diet (about 130 g/animal/day Kliba 341, Firma Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland)
- Water: About 250 mL tap water/animal/day
- Acclimation period: At least 15 hours before study start
- Animal identification: Ear tattoo

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours darkness/12 12 hours light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

8 d

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: Upper third of the back flanks (2.5 cm x 2.5 cm)
- Type of wrap if used: Test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: At the end ot the exposure period with lutrol and lutrol/water (1:1)
- Readings: 30 - 60 min after removal of the test patches and 24, 48, 72 h and 8 d after beginning of the study

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: 8 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Any other information on results incl. tables

Reading	Animal	Erythema	Edema	Symptoms
1h	1	1	0
	2	1	0
	3	1	0
24 h	1	2	0
	2	1	0
	3	2	0
48 h	1	2	0
	2	1	0
	3	1	0
72 h	1	2	0	S
	2	0	0
	3	0	0	S
8 d	1	0	0	S
	2	0	0
	3	0	0	S
Mean	1	2.0	0.0
	2	0.7	0.0
	3	1.0	0.0
Mean		1.2	0.0

S: scaling

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on this results, the test substance is not considered to be irritating to the skin.