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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.