Reaction mass of N,N-dimethylformamide and N,N-dimethylformamide hydrochloride

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Study period:

1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Referenced sources in an international report.

Data source

Reference

Reference Type:

review article or handbook

Title:

Dimethylformamide, SIDS Initial Assessment Report For SIAM 13

Author:

OECD

Year:

2001

Bibliographic source:

UNEP PUBLICATIONS

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: to Ulrich, P. et al.: Toxicology 125, 149-168

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

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

Test material form:

not specified

Details on test material:

No further data

In vivo test system

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

female

Details on test animals and environmental conditions:

Age: 6-8 weeks old

Study design: in vivo (non-LLNA)

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Vehicle:

other: DAE433, DMSO, DMF and acetone /oil olive (AOO)

Concentration:

Not reported

No. of animals per dose:

6 animals

Details on study design:

N,N-dimethylformamide was used as a vehicle in the present investigation. The publication describes the validation of a two-tiered murine local lymph node assay. Groups of 6 female BALB/C strain mice (6-8 weeks old) were used. During tier I a wide range of concentrations of test chemical solutions or vehicle (volume: 25 μl) were applied on three consecutive days to the dorsum of both ears. Mice were killed 24 hours after the last application to determine ear and local lymph node weights and lymph node cell counts. Ear weights were determined to correlate chemical induced skin irritation with the eardraining lymph node activation potential. For comparison of the induction and challenge responses, mice were treated on the shaved back with 50 μl of test chemical or vehicle alone on three consecutive days (induction phase treatment). Then mice were challenged 12 days after the final induction phase exposure with 25 μl of test chemical or vehicle on the dorsum of both ears for a further 3 days (challenge phase treatment). Lymph nodes were excised 24 hours after the final challenge phase treatment. A tier II LLNA protocol was used to finally differentiate between true irritants and contact allergens.
To investigate the impact of different vehicles on the primary response induced by two contact allergens, i.e dinitrochlorobenzene (DNCB) at 0.5% and by eugenol at 35%, DAE433, DMSO, DMF and acetone /oil olive (AOO) were used. Both contact allergens were compared either to the untreated control (aqua bidest) or to the corresponding vehicle control.

Results and discussion

Any other information on results incl. tables

Topical treatment of mice with the vehicle N,N-dimethylformamide led to slight ear-draining lymph node activation as expressed by increased weights and cell counts in comparison to the untreated animals. However, this observation was not reproducible in a second experiment (i.e. when DMF was tested as vehicle for eugenol and as vehicle alone in comparison to the respective untreated control group).

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Topical treatment of mice with the vehicle N,N-dimethylformamide led to slight ear-draining lymph node activation as expressed by increased weights and cell counts in comparison to the untreated animals. However, this observation was not reproducible in a second experiment.