N-methylformamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period 20 h and occlusive coverage conditions [worst case scenario]).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Skin irritation was tested using an internal method (BASF test)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-methylformamide

EC Number:

204-624-6

EC Name:

N-methylformamide

Cas Number:

123-39-7

Molecular formula:

C2H5NO

IUPAC Name:

N-methylformamide

Details on test material:

no details

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Body weight: 2.52 - 4.2 kg
no further details

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

The application site was covered with an cotton patch of 2.5 X 2.5 cm; patch soaked with the test substance and applied to the skin (appr. 1 ml); no further data

Duration of treatment / exposure:

1, 5, or 15 minutes (washing with Lutrol or 50% aqueous Lutrol) or 20 h (unwashed)

Observation period:

Results were recorded each working day for up to 6 days. 1st scoring 24 h after initiation.

Number of animals:

2 rabbits

Details on study design:

After the reported exposure time the skin was washed (not after 20 h exposure).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No effects were detected after 1 - 15 minutes exposure; data after 20 h exposure were presented in the Table below.
No edema was detected in any test group.

Other effects:

Body weight was slightly reduced (ca. 10%) in both animals after 20h exposure to ca. 1 ml undiluted test substance.
No further effects reported.

Any other information on results incl. tables

Skin erythema in 2 rabbits after dermal exposure to the undiluted test substance for 20 h

Time after initiation of exposure	20 hours exposure; erythema in
	Rabbit 1	Rabbit 2
24 h	2	2
48 h	1	2
72 h	0	1
6 days	0	0

-

Evaluation transformed to OECD-Draize scoring; no edema reported.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Conclusions:

The test substance has slight skin irritant properties.

Executive summary:

The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period 20 h and occlusive coverage conditions [worst case scenario]).

Two rabbits were dermally exposed to undiluted liquid test substance (ca. 1 ml) for 1, 5, 15 minutes or for 20 h. The coverage was occlusive; the skin was washed after exposure (not after an exposure period of 20 h). Skin reaction was scored 24, 48, and 72 h and day 7 after initiation. No effects were detected after 1 -15 minutes of exposure. Mean erythema score (24/48/72 h) after the 20 h exposure was 1 (animal #1) and 1.67 (animal #2); the effects were reversible. No edema was reported.

Conclusion: The test substance has slight skin irritant properties.