N,N-dimethylformamide

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1952

Report date:

1952

Reference 2

Reference Type:

publication

Title:

OECD SIDS Dimethylformamide, Final April 2004

Author:

OECD

Year:

2004

Bibliographic source:

OECD SIDS Dimethylformamide

Materials and methods

Principles of method if other than guideline:

- Principle of test: BASF method.
- Short description of test conditions: A patch is soaked with DMF and applied onto the skin on the back of the rabbits and fixed with a bandage. The neat test substance (about 0.5 mL) was administered for 20 hours. After bandage removal the application site was examined. In case of symptoms, examination was performed further until the findings disappeared.
- Parameters analysed / observed: Application site (erythema and edema score)

GLP compliance:

no

Remarks:

The study was performed prior to the adoption of GLP compliance.

Test material

Test material information

Constituent 1

Reference substance name:

Dimethylformamide

IUPAC Name:

Dimethylformamide

Constituent 2

Reference substance name:

N,N-dimethylformamide

EC Number:

200-679-5

EC Name:

N,N-dimethylformamide

Cas Number:

68-12-2

Molecular formula:

C3H7NO

IUPAC Name:

N,N-dimethylformamide

Details on test material:

- Name of test material (as cited in study report): N,N-dimethylformamide
- Analytical purity: 99%,
- Impurities (identity and concentrations): about 1 % Methanol, traces of Monomethylformamide and Formamide

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

data not available

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): undiluted and as 50 % solution in water.

Duration of treatment / exposure:

20 hours

Observation period:

48 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: shaved back of albino rabbits.
- % coverage: 2.5 cm X 2.5 cm big patch
- Type of wrap if used: patch fixed with a bandage.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 20 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 24h, 24h/48

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.25

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: 72 h data missing

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: 72 h data missing

Irritant / corrosive response data:

Only one of the four animals showed faint redness on the first day after removal of the bandage.

Other effects:

no

Any other information on results incl. tables

Mean erythema score after 24 and 48 h (72 h data is missing); (animal 1/animal 2):

Conc.	24 h	48 h	mean
100%	1/0	0/0	0.5/0
50%	1/0	0/0	0.5/0

Mean edema score after 24 and 48 h (72 h data is missing); (animal 1/animal 2):

Conc.	24 h	48 h	mean
100%	0/0	0/0	0/0
50%	0/0	0/0	0/0

Applicant's summary and conclusion

Interpretation of results:

other:

Remarks:

EU GHS criteria not met

Conclusions:

Only one animal showed faint redness on the first day after removal of the bandage. On the second day there were no more findings. The other animal was without any findings. Under the present test conditions DMF was not irritating.

Executive summary:

Study design

This non-GLP in vivo study was performed comparable with OECD guideline study. The neat substance (about 0.5 mL) was administered for 20 hours on the shaved back of 4 albino rabbits. For this purpose a 2.5 cm x 2.5 cm big patch was soaked with the test substance and applied onto the skin and fixed with a bandage. After removal of the bandage the application site was examined and in case of findings, observation continued until the findings disappeared.

Results

Only one animal showed faint redness on the first day after removal of the bandage. On the second day there were no more findings. The other animal was without any findings.

Conclusion

Under the present test conditions DMF was not irritating.