Formamide

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: Comparable to guideline studies with acceptable restrictions. Extented exposure period; short observation period. Extrapolation of the effects to 4-hour exposure conditions is, however, possible.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: BASF; internal guideline

Principles of method if other than guideline:

2 mL of undiluted test substance was applied to the intact skin of two rabbits under occlusive dressing for 20 hours. Skin reactions were scored on days 1, 2, 3, and 5 after application similar to the scores contained in teh OECD guideline No. 404.

GLP compliance:

no

Remarks:

Pre-guideline, pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

Formamide

EC Number:

200-842-0

EC Name:

Formamide

Cas Number:

75-12-7

Molecular formula:

CH3NO

IUPAC Name:

formamide

Details on test material:

Formamide, degree of purity not reported.

Test animals

Species:

rabbit

Strain:

Vienna White

Test system

Type of coverage:

occlusive

Vehicle:

other: no vehicle

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

20 hour(s)

Observation period:

5 days

Number of animals:

2

Results and discussion

In vivo

Results

Remarks on result:

other: Formamide (shaved back skin of 2 rabbits, 20 h under an occlusive dressing). Result: marked erythema at 24 h and slight erythema at 24 and 48 h after initiation of treatment. Erythema was absent on day 5, and scaling was seen at the treated sites.

Any other information on results incl. tables

The ear showed no irritation at any reading.

Reactions of the back skin were as follows:

- 1, 5, and 15 minute exposures: no skin reactions

- 20 hour exposure: slight to moderate erythema in one rabbit, and very slight (questionable) erythema in
the other rabbit. At the 8-day reading, slight scaling was observed in both rabbits at the treated site.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Executive summary:

Formamide, applied to the shaved back skin of 2 rabbits for 20 hours under an occlusive dressing, caused marked erythema at 24 hours and slight erythema at 24 and 48 hours after initiation of treatment. Erythema was absent on day 5, and scaling was seen at the treated sites.

A 20-hour occlusive exposure exceeds by far current test guideline exposure conditions and represents very severe conditions. Only very slight signs of irritation were seen under these conditions. Therefore, the type and severity of the effects suggest that formamide is not irritating when these results are extrapolated to a 4 -hour exposure period.